On Sunday 27th April, the British Channel 4 broadcast a documentary entitled "Dying for Drugs" which went into detail into "how far drug companies are prepared to go to get their drugs approved and get the prices they want". The documentary was such a strong and emotional denunciation of the policies and practices of the big pharmaceutical companies that at least one of them (Pfizer) was forced to publish a response in their web site.
Basing itself on four different cases, the program made a very powerful case for its main conclusion: "if the Big-Pharma powers remain unchecked soon many more people will be dying for drugs."
Human guinea pigs
The first thing the documentary explained was how the big pharmaceutical multinationals are increasingly using Third World countries as the place to carry out medical trials for new drugs, away from the strict scrutiny of European and US governments.
The example was that of Annas, a 6-year-old boy who became infected with meningitis in the Northern Nigerian town of Kano in 1996. An outbreak of meningitis was added to another two epidemics raging the region at that time. These epidemics went almost unnoticed outside Nigeria, but they were picked up at the headquarters of drug giant Pfizer which quickly sent a plane with a team in order to carry out medical trials for a new drug, a potentially billion dollar spinner. The new drug, trovafloxacin, known by its commercial name of Trovan, had never been tested on children before.
The meningitis epidemic affected more than 150,000 people and more than 15,000 died by the time it ended. At the Kano Infectious Diseases Hospital the international aid organizations Medicins Sans Frontiers (MSF) treated thousands of patients with known and tested methods.
At the same time a Pfizer team set up a "Pfizer Meningitis Study", a medical trial for Trovan. The rules on trials like these are very strict and have been regulated since the end of World War Two by the Nuremberg Code. The first and most important rule in this code is that the patient (or in this case the parents) have to give voluntary consent to participate in the trial after all the risks have been properly explained and understood.
The program claims that Pfizer did not get written consent from any of the parents of the children involved in the trial. Pfizer replied that many of them did not speak English and many were not able to read or write. But Annas' father explained that he is fluent in English and can read and write in English, Hausa and Arabic. Furthermore the documentary makers were told by at least 100 sets of parents, out of the 200 involved in the trial that they never gave any consent simply because they were not asked to! A group of them are now suing Pfizer over this case.
Another major requirement of the Nuremberg code is that an independent Ethics Commission must approve the trial. Pfizer produced such a letter of approval from the Aminu Kano Teaching Hospital Ethics Commission. But when challenged by the families' lawyers about the fact that the letter was dated March 28, 1996, when no such commission existed at that Hospital, the company had to admit that the letter has been backdated and was based on a "verbal agreement".
Clearly Pfizer committed serious irregularities in the rush to get their medical trial for a potentially multimillion dollar new drug. Furthermore, Annas, the boy in the documentary, is now suffering from severe knee pain that prevents him from running or playing football with his friends. As the local doctor explained, joint pains were a known side effect of Trovan before the Kano trial. It is not possible to determine whether Annas' knee trouble was directly caused by Trovan, but what is certainly clear is that his parents never gave consent to participate in any Pfizer medical trial, because they were never asked. When the severely ill boy was taken to a white doctor, they thought this was no different from the other patients being treated at the Infectious Diseases Hospital. No one told them otherwise.
Another case mentioned in the documentary was that of a little girl, "patient 69". She only weighed 3 stone (19 kilos) when she was admitted and was administered an oral dose of Trovan. On the second day, despite the fact that her condition had clearly deteriorated, the Pfizer doctors decided to continue with the treatment. On the third day she died. As the local Kano doctor pointed out, it is standard procedure to change the treatment if the patient does not respond. "I think they played with that baby's life", he added.
To this day Pfizer remains satisfied that the Kano trial was "correctly pursued". But the most damning piece of evidence presented in the documentary was a copy of a letter written by Juan Waltenspield, Pfizer's own Childhood Disease specialist and addressed to the company's chairman. In this letter, doctor Waltenspield listed eight major objections against the trial, including the fact that Trovan had never been tested before for that kind of meningitis, the fact that oral administration of the drug was not recommendable for patients suffering from severe malnutrition and also the lack of written consent. Doctor Waltenspield was sacked shortly after sending this letter and had difficulty finding another job. Trovan has since been withdrawn from the market because of its harmful side effects.
The documentary also explained how this is far from being an unusual case, as more and more pharmaceutical companies move their medical trials to underdeveloped countries, basically because it is easier to "bend the rules" there than in advanced capitalist countries. The main conclusion is that they are using humans as guinea pigs without asking for their permission in order to get drugs approved quickly and start making money.
"Don't like the results? Shoot the messenger!"
The documentary then goes on to make the case that the drug multinationals use all sorts of pressures to get their new drugs approved. The example used is that of Doctor Nancy Olivieri, director of the Thalassaemia research centre at the Toronto Hospital for Sick Children, one of the largest paediatric institutions in the world. Doctor Olivieri was looking for an alternative method for thalassaemia sufferers. The sufferers of this disease do not produce enough blood cells and have to have a blood transfusion every few weeks. A side effect of this treatment is that the iron from the haemoglobin administered will eventually destroy their hearts and livers if unchecked. Thus they have to get a drug administered to flush out the iron. This is currently done through needles in a two-hour daily ordeal.
So when a new drug, L1, was discovered as an alternative method of checking the iron levels, drug giant Apotex Inc decided to fund the medical trials and Doctor Olivieri was put in charge. This is quite a common practice. A private pharmaceutical company funds medical trials for drugs which have been discovered and developed by publicly funded hospitals and institutions, and then it gets all the rights over the final product. (By the way this largely destroys the myth propagated by the multinational companies that the high prices of their drugs are justified in order to pay for the research that has gone into developing them. In fact, in many cases, the companies have nothing to do with research, but limit themselves to buying other people's research carried out in publicly funded institutions).
Doctor Olivieri's trial for L1 was initially successful and showed encouraging results. But then the levels of iron in some of her patients started to increase and she wanted to modify the trial. When she arrived home there was a message on her answering machine from Apotex vice-president Mike Spino. This was a really threatening message in which she was told in no uncertain terms that the L1 clinical trial were suspended, she was sacked from her position at the head of it and that L1 was to be brought onto the market as soon as possible. Furthermore she was to tell no one, not even her patients involved in the trial, about her findings, and if she revealed them they would take legal action against her.
Basically, Apotex did not like the results of the medical trial and therefore the trial was cancelled. From the point of view of Apotex, the most important thing was to get the new drug (which they had not even researched themselves) onto the market and start making money. Why let a few facts spoil a good business opportunity?
Since Doctor Olivieri stood by her findings, she was subjected to a campaign of threatening letters and phone calls that left her "extremely frightened and extremely intimidated". As she started to link up with other doctors in the hospital, they in turn were also subjected to threats. In one case a doctor started receiving anonymous threatening letters. Finally, through DNA testing, it was established that the letters had been written and sent by another doctor at the same hospital who was still receiving Apotex funding for his projects!
Multinational pharmaceutical companies have a lot of money and they can use it to pile on enormous pressure to get things their way. At the time when the polemic about the L1 trial was going on, Apotex was negotiating a multimillion-pound donation to fund a new building for the University of Toronto, of which the Hospital is a part. Doctor Olivieri was subsequently dismissed from her position as Director of the Thalassaemia research programme!
Because, unlike many other doctors, doctor Olivieri maintained her objections to the new drug, Apotex decided to move their attempts to get the drug approved far from Toronto and into Europe. Finally in 1999 the European Commission licensed L1. Olivieri and a team of other doctors are currently appealing against this decision. As she said in the programme, "I might be right or wrong, that is not the case. The main point is that whether the drug is safe or not has not been determined yet".
In trying to disprove doctor Olivieri's findings Apotex produced a list of 3,000 "errors" she had allegedly committed during the trial. An independent expert went through the data and found the allegations almost completely baseless. But already months of hard work had gone into clearing up Olivieri's data.
After Doctor Olivieri went public in her battle against Apotex, she received hundreds of letters from other doctors who had been on the receiving end of leading pharmaceutical companies' strong-arm tactics when they didn't like their results. Some had been followed by private investigators, others forced out of their jobs and even out of their countries, etc.
Even the editors of prestigious medical publications, including The Lancet and the Journal of the American Medical Association, have admitted being pressurised by the Big Five (the five pharmaceutical multinational giants that control the sector worldwide). The same is true of university institutions that rely quite a lot on private funding.
Once again, the main interest of Big Pharma is to make money, and they will go even against medical science if it gets in the way.
"Thank you very much, you can die now"
This seems to be the philosophy behind the actions of the drug multinationals in the documentary's third case study. Leukaemia sufferers in South Korea participated in medical trials for a new drug by pharma giant Novartis and when the drug was approved it was priced at such a high price that these same patients are now unable to buy the drugs and will probably die as a result.
The documentary follows the case of leukaemia sufferer Mr Yoong. He was in a terminal stage of his illness and was told he had six months to live. Understandably he made sure he was one of the first patients to join medical trials for Novartis' new drug Glivec. The drug was very successful and fourteen months later he is still alive. The new drug was approved in record time and is now out on the market. Novartis decided to sell it to patients in South Korea at $19 a tablet. This means that at 8 tablets a day, a year's treatment would cost $55,000, an amount that is too much for many of the patients who participated in the trial. Mr Yoong has had to sell his house and move with his wife and daughter to a small flat. Meanwhile, Novartis sold half a million pounds worth of Glivec tablets last year. And that is really what matters to them.
One of the reasons why new drugs on the market are so expensive is WTO patent regulations which give the pharmaceutical companies exclusive rights for 20 years. This means they can sell them at whatever price they want because they face no competition.
The documentary makes another point that further undermines the Big Pharma argument that prices are high in order to fund research into new drugs. As an MSF spokesperson explains, most new drugs that come onto the market are "mee-toos", i.e. small variants of drugs that already exist. Also research decisions are made on the basis of profitability. The Big Five are quite happy to invest in research for "lifestyle drugs", for instance yet another drug for erectile dysfunction, since there is a market in the advanced capitalist countries for them. But they have no interest whatsoever in researching drugs to treat multi-million killer diseases like tuberculosis or malaria (which kill 6 million people a year) because these affect mainly people in underdeveloped countries who will not be able to pay for them. In other words, there is no market for them. In any case, as we have already seen, many of these drugs have been developed in publicly funded institutions in the US, and the drug companies just buy the right to use them.
When the WTO patent rules were approved a safeguard was introduced. In certain cases governments can file for compulsory licensing, which overrules the companies patent rights and allows them to buy or produce generic versions of the same drugs. Having a strong generic sector has allowed a country like Brazil to produce cheaper versions of some drugs and to be in a stronger bargaining position to get lower prices from the big drug companies. For instance Brazil has been offered Glivec at $8 a tablet, as opposed to the average world price of between $20-25. But as we know, "the law is like a spiders' web, the small get caught but the rich and powerful tear it apart". In a capitalist world, furthermore in the epoch of imperialism, the big multinationals have powerful resources to fight against any laws that don't suit them, or to get them changed.
Imperialism at work
Mr Yoong and a group of former Glivec trial patients decided to make application for compulsory licensing in July 2001. As the South Korean Ministry of Health was studying the application, it received a letter from the US Secretary of Commerce threatening them that if they decided to use compulsory licensing against Novartis, the case could escalate into a full blown trade dispute. Shortly afterwards the Minister got dismissed in a Cabinet reshuffle. He went public denouncing the role of the pharmaceutical multinationals in his dismissal. In other words, Novartis has enough power, through the US administration, to remove a Minister from a sovereign nation if its interests are threatened!
The documentary also explains how the Thai government was also threatened by Washington over its attempt to use generic versions of AIDS drugs. Thailand was threatened with increased tariffs on wood and jewellery, which account for 30% of the country's exports, and was forced to retreat.
More recently Washington blocked a proposed change to WTO rules that would have favoured the production of generic versions of drugs. The changes had been agreed by all countries but were blocked by the US. It is no surprise though that Donald Rumsfeld is himself a former Big Pharma executive.
What makes these cases even more outrageous is that what we are talking about here are not merely trade disputes, but trade disputes over one particular commodity that is a matter of life or death for hundreds of thousands of patients.
Incidentally these examples by themselves refute the new theories about the existence of a new Empire without any national base. Clearly, old fashioned imperialism, in which powerful conglomerates of nationally based multinationals and banks dominate the world through the national states they are based in, is very much alive.
The Glivec trial patients group then decided to go to India, which also has a strong generic drug sector, to see how much it would cost to produce a generic version of Glivec. Doctor Yusef Hamied, director of Indian pharmaceutical company Cipla tells them that his company could get the drug to patients at a price of less than $1 a tablet (as opposed to the nearly $20 Novartis price). Doctor Yusef claims to have a "humanitarian approach to business", but as the documentary makers comment, he has to compete not so much against the big multinationals but rather against the other local generic drug companies that are offering prices similar to his. The real reason why his company sells drugs at very low prices probably has more to do with the particular market forces he has to fight against, than any "humanitarianism" on his part. Finally the patients group did not succeed and in February 2003 there was a ruling against compulsory licensing of Glivec in South Korea. Once again profits were put before people's lives in a very concrete way.
The reason why India has a strong generic sector is because of the country's peculiar patent laws that allow companies to patent the way a drug is made rather than the drug itself. This means that Indian generic companies can devise an alternative method of producing the same drug and stay within the law. The WTO is now demanding that India change its laws to offer full patent protection from 2003. The interests of Big Pharma will again be guaranteed.
Drug prices kill
The last example in this brilliant documentary is that of Jairo a 12-year-old AIDS orphan from Honduras who is HIV positive himself. There are over 14,000 AIDS orphans in the country and more than 60,000 HIV positive people.
Jairo has developed oral thrush and needs fluconazole, a drug patented by drug giant Pfizer under the commercial name of Diflucan. Pfizer sells $1bn worth of Diflucan a year, which is priced at $27 a tablet in Honduras. Jairo is cared for by his aunt. Her husband's wage is about $90 a week. Jairo's weekly supply of Diflucan would cost $189. As an AIDS worker says, "the price of anti-retroviral drugs and drugs for opportunistic infections are killing our people".
Jairo's family and AIDS workers are forced to go over the border to Guatemala where they buy a generic version of fluconazole for 30 cents a tablet and smuggle them over the border, risking being arrested.
But even this is too late for Jairo. The documentary actually shows the terrible images of Jairo dying on his way to hospital, completely emaciated, reduced to skin and bones by HIV related infections. This is one of the most damning denunciations of the policies of the drug companies ever shown on TV.
One of the South Korean leukaemia patients who were in the Glivec trials says to the documentary makers: "if a poor person does not get access to a drug, this does not increase the company's profits, it just make the poor suffer". This is quite true, but for the pharmaceutical company to make concessions in one particular case would mean that it would be put under extreme pressure to make concessions in all other cases. And this would be very bad for business.
At the end of the day every single one of the practices of Big Pharma, also known by drug campaigners as the Pharma-Mafia, shown in the documentary are repulsive from a human point of view. But we should not think that the Pharma-Mafia CEOs use these methods because they are particularly nasty or insensitive people (surely many of them are). The real reason is because they are producing to make a profit. It is a twisted, horrible, inhuman logic, but it is the logic of capitalism after all. This is therefore one of the best examples of the contradiction between the private property of the means of production and the needs of humankind.
Documentaries like this are excellent exposures of the way these callous multinationals operate, without any regard for human life. The domination of the world drugs market by five massive multinational companies is the direct cause of death for millions of people around the world every day. The case for the nationalisation and democratic control of these five giants is clear. The moral outrage this documentary creates must be channelled in the right direction, that of the struggle against capitalism itself.
- Drugs companies putting profits before millions of people's lives. By Jordi Martorell