Healthy Skepticism Library item: 19011

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Publication type: Broadcast

Tinari S, Häner H, Padrutt R
The Tamiflu Saga – A pandemic business
Falo and Rundschau : RSI and SF 1 2011 Jan 120

Full text:

TC 01’09 OFF Tom Jefferson, epidemiologist Cochrane Collaboration (interview in Italian)
A banal disease such as Influenza or influenza-like illness has become a worldwide veiled threat, with committees, guidelines, drugs stockpiling… A thriving industry that produces vaccines, antiviral drugs and other remedies whose effectiveness is far from being fully proven.
TC 1’40 Roche promotional material (English)
Not a winter goes by without it. The invasion of the flu virus. Year after year, each winter one out of every 10 persons comes down with the flu. In north America, in Europe and Japan alone more than 100 million people are affected.
TC 2’13 commentary
The hero to fight the monster is called Tamiflu and it comes from Switzerland. It’s not the only existing antiviral drug, but it’s the one that conquered the market. In order to face the pandemic threat, governments all over the world stockpiled it for their populations. Tamiflu is a blockbuster for Roche. But is it an effective and safe drug?
TC 2’46 Fiona Godlee, editor in chief British Medical Journal (English)
We cannot say whether it is effective or not. It’s certain, that it doesn’t seem to be any more effective then Paracetamol in terms of changing the symptoms of flu. And Paracetamol is quite a safe and cheap drug, whereas Tamiflu is an expensive drug and seems to have some harmful effects.
TC 3’08 Samantha Millard (English)
When they took some skin away and test it, so I even didn’t had the swine flu, so I was given tablets for something I didn’t have, they’ve now sent me blind.
TC 3’22 Deborah Van Horenbeeck, Samantha Millard’s Mother (English)
I am a hundred percent certain it was the Tamiflu. I do hold the government and Roche both responsible for what they’ve done to my daughter.
TC 3’40 Ryuko Hatano, Tamiflu Victim Association (Japanese)
My son had gotten influenza multiple times before the year he died, but he had never showed any abnormal behavior. TC 3’52 I am furious that with this they are still claiming that Tamiflu is safe.
TC 4’01 Stephen Toovey, Tamiflu Team, Roche (English)
We know that influenza is a killer and we need a drug that treats influenza. But we need a drug that is safe as well. And that’s really why you have to look to the regulators, to the health authorities, to decide based on all the evidence, whether the drug is safe or not. And their conclusion is pretty clear, it is safe and effective.
TC 4’26 commentary
Tamiflu, whose active principle is called Oseltamivir, was created at the Gilead Sciences Laboratories, a pharmaceutical company based in California. Gilead synthesized the drug from star anises, a Chinese spice. In 1996, Roche signed a deal with Gilead: for 10 million dollars plus a percentage on the sales, the Swiss industrial giant bought itself the right to sell Tamiflu all over the world. The new drug is supposed to prevent the Influenza virus from spreading inside the body, a revolutionanary mechanism of action.
TC 5’06 Even so, the early years were pretty tough. The clinical studies had shown that Tamiflu reduced the duration of the symptoms by only a day and a half. Not much, compared to traditional interventions. Moreover, Tamiflu could only be bought with a prescription.
TC 5’22 In the beginning the sales weren’t great, and the industry knew why. In 2001, the Swiss paper NZZ Folio published an article where for Roche a Mathias Dick explained the company’s marketing strategy to bring this drug into every home.
TC 5’37 NZZ Folio. Voice-over (man). (German).
For 70 years we have said: if you catch a flu, stay in bed. Now we have to convince people to go and see a doctor.
TC 5’47 Commentary
When Tamiflu came to the market, in fact, influenza was still the most common disease you could catch. You had to watch out for it if you were an elderly person or if you had some other chronic disease, but it wasn’t at all such a global emergency.
TC 6’02 Then came the avian influenza, H5N1, a virus you catch from a bird, but we have been told, it could mutate and decimate the population. The World Health Organization was worried.
TC 6’19 Klaus Stöhr, WHO — 12 november 2004 (German)
It’s a mathematical model, we’ll have to wait and see what really happens. We estimate it could kill 17 millions people.
TC 6’27 commentary
In doubt, countries stockpiled Tamiflu. Millions of doses ended up in storages. The avian pandemic never came, and for a while, no one mentioned Tamiflu anymore.
TC 6’43
Then came the swine flu, H1N1. The WHO has warned: Swine Flu could turn out to be like the 1918 Spanish Flu. It had killed 40 millions people.

TC 7’12 (Graphic) Roche has cashed in hundreds of millions of Swiss Francs by selling drugs during the avian flu alert and hundreds of millions during the swine flu alert. About 12 billions swiss-francs were cashed in within ten years.
TC 7’28 The stocks have remained more or less untouched, because, fortunately, both the avian and the swine flu have never become the foreshadowed plague. In order to face the threat, governments had to do something, as a precaution.
TC 7’51 The Public Health authorities never cared, though, if thanks to Tamiflu, you would spend one day less in bed.The important thing was that the drug was effective on the complications of the flu: pneumonia, bronchitis, hospitalizations … If these were to affect millions of people, you can imagine what a disaster it would be. TC 8’19 At the end of 2004, during the avian flu alert, Roche had spread the word that Tamiflu can do it. The drug had proved effective against the influenza’s complications. It had been demonstrated by a study of a Swiss virologist, Professor Kaiser.
TC 8’44 Laurent Kaiser (French)
Laurent Kaiser, professor of virology at the Geneva Hospital and University.
TC 8’56 Rome
TC 8’58 commentary
In 2006, Tom Jefferson, of the Cochrane Collaboration, published a study based on Kaiser’s research on The Lancet, one of the world’s leading biomedical journals. Cochrane is an independent research network which is widely appreciated for its scientific correctness. They specialize in reviews. They gather all the studies that have been published on a specific topic, they choose the best quality ones and they put them together. It’s a foolproof method.
TC 9’25 Jefferson’s review on Tamiflu concluded that its benefits were small but that, thanks to Kaiser’s research, the drug could be expected to be effective on the complications of the flu.
TC 9’37 Tom Jefferson, epidemiologist Cochrane Collaboration (Italian)
This article presentes evidences that Tamiflu reduces the complications of influenza, that is pneumonia, bronchitis and so on. Kaiser’s study represents one of the main reasons why countries stockpiled thousands, billions, I don’t know how many doses of Tamiflu.
TC 10’08 commentary
In the summer of 2009 a Japanese pediatrician noticed there was a serious problem in Kaiser’s study and, consequently, in the Cochrane review. The evidences for Tamiflu’s effectiveness on the complications had never been published.
TC 10’24 Keiji Hayashi, pediatrician (Japanese)
My name is Keiji Hayashi. I run a small pediatric clinic in Osaka. This is my wife Yasuko – she’s a pharmacist.
TC 10’42 commentary
During the swine flu pandemic, the Japanese government too recommended Tamiflu. A scrupulous man, pediatrician Hayashi decided to examine the data that had been published by Kaiser and reviewed by Cochrane, to make sure Tamiflu was really effective against the complications of influenza.
TC 11’00 Keiji Hayashi, pediatrician (Japanese)
His literature reviewed ten data. I found that two had been published. When I looked at the two data, I found that Tamiflu lacked superiority in preventing complications such as bronchitis. So actually the eight remaining data, that are not published, are the ones that prove Tamiflu’s effectiveness in preventing complications. And another thing is when looking at the authors’ affiliation; four aside from Kaiser were from Roche. And another was a consultant who is paid by Roche. So I thought the literature was basically written by Roche.
TC 12’18 commentary
The Japanese pediatrician found out that the data could not be verified. The news was a bolt out of the blue for doctor Jefferson.
TC 12’39 Tom Jefferson (Italian)
I am Tom Jefferson, I am a medical doctor, I am an epidemiologist and my life has been changed by doctor Keiji Hayashi, a Japanese pediatrician I have never met.
TC 12’50 commentary
Jefferson lives in Rome. Once had worked as a consultant on Tamiflu for Roche. Today, he’s troubled.
TC 12’59 Tom Jefferson, epidemiologist Cochrane Collaboration (Italian)
We made a mistake with that review. So my first reaction was that I, as they say, had “pulled a boner” with my team of reviewers. We had made a mistake, we hadn’t examined it thoroughly enough. My fault.
TC 13’16 commentary
Troubled, Jefferson wrote to the authors of the studies asking them to send him the complete original data-set that had not been published. The replies he received left him speechless.
TC 13’31 Tom Jefferson, epidemiologist Cochrane Collaboration (Italian)
I sent 4 e-mails and received 3 replies. One of the people I wrote to never wrote back. All three replies were exactly the same: they didn’t have access to the data and referred me to Roche.
TC 13’49 commentary
But what does it mean that the manufacturer of the drug is the only one who has access to the full data-set? We went and ask someone who knows a lot about scientific studies.
TC 14’03 Fiona Godlee (English)
My name is Doctor Fiona Godlee, editor in chief of the British Medical Journal, which is owned by the British Medical Association. The BMJ’s mission is to help doctors make better decisions.
TC 14’22 Fiona Godlee, editor in chief British Medical Journal (English)
In this case almost all of the data is in the hands of the manufacturer of the drug. So the data were generated by employees of the company, they were evaluated by employees of the company, they were authored by employees and people paid by the company – academics paid by the company. So we have no independent evaluation of this drug and because the data aren’t available we have to say, we cannot judge the effectiveness of this drug.
TC 14’58 commentary
It’s not a coincidence that this bizarre story began in Japan.
TC 15’05 The Land of the Rising Sun is Tamiflu’s true home country. Before the pandemic emergencies, in fact, 80% of the global production of this drug had been sold in Japan as a remedy against the seasonal flu. Chugai, a Roche subsidiary company, is in charge of the Japanese market.
TC 15’32 Pediatrician Hayashi knows Tamiflu well.
TC 15’38 Keiji Hayashi, pediatrician (Japanese)
When Tamiflu was first marketed, I was using it, but I later found out that there are many side effects, so I have been trying my best to stay away from Tamiflu. Sometimes, there are mothers who come to tell me that they have had terrible experiences with Tamiflu. For example, a two-year-old son suddenly grabbed a pair of scissors and started going wild with them. Or a mother told me about a gigantic eraser that was attacking her, so she kept fighting and avoiding the gigantic eraser throughout the night. So she was having delusions. When she told her husband about this the husband didn’t believe her and took the drug himself. Then he had delusions where he was flying over the clouds.
TC 17’03 Ryuko Hatano, Encephalopathy Tamiflu Victim Association (Japanese)
Someone brought up the idea the first time, and every year when the time comes around, we have friends gathering for his birthday. We have been gathering for his birthday every year since his death.
TC 17’41 Kohei got a fever on February 4th 2005, so I left him resting until the following day, the 5th of February. It was a Saturday. When he took his temperature it was about 39 degrees. So he went to a doctor nearby around 11AM. He was diagnosed type A influenza and was prescribed Tamiflu. So I told him to sleep in the bed in his room, right by the front door. I woke up when I heard the door open. TC 18’39 I looked around for him, but he couldn’t be found in the apartment, so I went out the front door to find commotion that someone had fallen from the building. I didn’t think that it could be my son, but since he wasn’t home, I went down to the ground floor parking lot and found that it was my son.

TC 19’19 Ryuko Hatano (Japanese)
My name is Ryuko Hatano, representing Drug Disaster Tamiflu Encephalopathy Victims Association.
TC 19’29 commentary
For 5 years, Mrs. Hatano has been pressuring the public opinion to acknowledge Tamiflu’s dangerousness. In 2010, she sued the japanese regulatory authorities – the court case is open. In Japan, doctors have reported to health officers almost 800 cases of serious neuro-psychiatric adverse events in patients who had taken Tamiflu. Among these cases there were around 70 casualties. It’s hard to find a ratio to the millions of people who have taken the drug over a ten-year period. But what is Roche comment about these events?
TC 20’01 Stephen Toovey (English)
I am doctor Stephen Toovey, I am a doctor and a scientist, I am a medical scientist working in the Tamiflu team at Roche in Basel.
TC 20’12 Stephen Toovey, Tamiflu Team, Roche (English)
Essentially the Japanese they realized quit a long time ago that influenza was serious and needed to be taken seriously so they are more aware of these kind of events, they know that influenza must be taken very seriously.
TC 20’27 journalist RSI (woman) (English)
So you mean that the neuropsychiatric adverse events reported in Japan are actually NOT related to Tamiflu?
TC 20’35 Stephen Toovey, Tamiflu Team, Roche (English)
If you look at what’s happening in Japan and in other countries, you can see that influenza causes these kind of events, you are quite correct.
TC 20’49 commentary
The Japanese cases made big waves, even though in Europe few heard about them. In Tokyo, the authorities commissioned a scientific study to clarify the matter. The results showed that psychic alterations had been observed in 10% of young people with influenza, and in 12% of people with influenza who had taken Tamiflu. Not such a big difference.
TC 21’13 In 2007, the scientific journal Nature revealed that some of the scientists who had taken part in that study had received financial support for other researches from Chugai, the Roche subsidiary company that distributes Tamiflu in Japan. Doubts arose on the independence of the study on the neuro-psychichiatric adverse events of Tamiflu.
TC 21’36 As a precaution, the government decided that Tamiflu can’t be prescribed to young people between 10 and 19 years of age.The warning against psychiatric side-effects appeared on the Patient Information leaflets all over the world. In fact, similar side-effects in patients who have taken Tamiflu
have been reported worldwide. It’s impossible to make an estimate. It’s hard to determine a causal link between a drug and a side-effect. But Roche is sure that these cases have not been caused by its remedy against the flu.
TC 22’15 Stephen Toovey, Tamiflu Team, Roche (English)
Influenza can be associated with accidental death, people imagine in a complete delusional state, they imagine they are somewhere else, or they imagine that they have suddenly gained the power to fly. You know, these are tragic events because the results of these events are tragic, but what you need to do, is to treat these people effectively and you need to get there infection under control and for that you need an effective antiviral drug like Tamiflu.
TC 22’58 Roche promotional material (English)
The symptoms start suddenly. Headache, the muscles and joints hurt. The victim is exhausted. The patient feels hard and cold and start to shiver. Within just a few hours a fever has developed, in some cases very high. Sometimes a dry cough and a sore throat occur. With these symptoms plus the body feeling like a dead weight the victim has only one wish, to get to bed.
TC 23’25 journalist RSI (woman) (French)
How often have you come across cases of influenza patients who commit suicide?
TC 23’33 Laurent Kaiser, virologist (French)
I have never come across one. You refer to studies on children that have been published in Japan. I have never had a patient like that. Sometimes elderly people with a high temperature can show signs of disorientation, but not suicide, never.
TC 23’59 commentary
In the meantime, doctor Jefferson keeps on hunting for the missing data. Initially, Roche makes itself available and tells the Cochrane Collaboration they will be given the original data-set so that they can examine it. On one condition, though. Jefferson must sign a confidentiality agreement according to which, he will not be allowed to either publish the data nor tell publicly that such agreement had ever took place.
TC 24’28 Tom Jefferson, epidemiologist Cochrane Collaboration (Italian)
We never sign confidentiality agreements because our goal is to make our results public. There are industrial secrets but once a drug is on the market why would you hide the data based on which you made your decisions, the scientific evidence on which you have based your decisions? The drug is on the market. I don’t understand.
TC 24’59 commentary
The British Medical Journal decided to report about this strange story. BMJ feature includes the account by a former employee of a communication agency. This person says she collaborated in taking care of the editorial aspects of the studies on Tamiflu effectiveness. Studies that were authored by renowned scientists. The woman is a ghost writer, and she supplied papers that confirm her testimony. She explains:
TC 25’34 voice-over (woman) – (English quote from British Medical Journal)
We were under pressure to get messages out. The Tamiflu accounts had a list of key messages that you had to get in. it was run by the marketing department and you were answerable to them. In the introduction for Tamiflu, I had to say what a big problem influenza is. I’d also had to come to the conclusion that Tamiflu was the answer.
TC 25’56 commentary
Ghost writers, authors who don’t have the data that lie behind the studies they have authored. It’s absurd. Roche intervenes and reassures.
voice-over (man) – (English – quote from British Medical Journal)
Roche has now disclosed (7 December 2009) on roche-trials.com the study summaries (including key data) relating to the Kaiser manuscript. The corresponding full study reports will also be made available on a password-protected site within the coming days to physicians and scientists.
TC 26’27 commentary
The British Medical Journal editor in chief is puzzled.
TC 26’34 Fiona Godlee, editor in chief British Medical Journal (English)
It is pretty crazy it seems to me that the public must rely on investigative journalist, journal editors, academics like the Cochrane collaborators to unpick the story in this way, it shouldn’t be like that, it should be, the public has the right to much much better information, open information about the drugs that they are taking. And the idea that it depends on you, me, the Cochrane collaborators digging around in this very ad hoc fashion seems completely wrong, mad.
TC 27’11 Geneva
TC 27’14 commentary
So, let’s go and talk to the Swiss Kaiser who, despite himself, became famous because of this controversy. Even though he’s pretty young, not even 50 years old, Kaiser is director of the virology laboratory at Geneva’s Canton State Hospital.
TC 27’32 jornalist RSI (woman) (French)
Did you personally see and analyze the primary data?
Laurent Kaiser, virologist (French)
Of course, that is the basis of our academic activity. I find this question almost insulting.
TC 27’45 journalist RSI (woman) (French)
After all the waves the BMJ feature made, did you review the data again?
TC 27’57 Laurent Kaiser, virologist, (French)
Listen, I am not able to analyze these data in detail, alright? My job as a researcher was to verify whether the analyses had been correctly performed, whether they were consistent, or they carried bias. You can’t tell if someone is hiding you the truth or presenting you manipulated data. But this is another issue. I was never under the impression that I was working with false or manipulated data.
TC 28’36 Oxford
TC 28’42 commentary
The Cochrane Collaboration decided to start all over again and analyze all the available data on Tamiflu and on the other anti-viral drugs, effectiveness.To carry out this project, they created a new group of scientists who met for the first time in Oxford, England.
TC 28’59 OFF Tom Jefferson, epidemiologist Cochrane Collaboration (Italian)
There are seven of us and we come from four different continents. We use English as our “lingua franca”. We talk through Skype or via e-mail because we are penniless! We receive funds from the English government to perform this review, but they are pretty meagre.
TC 29’18 Peter Doshi (English): Peter Doshi, Massachussets Institute for Technology. After many months of our investigation, we were left with the doubt that Tamiflu is not any better then aspirin.
TC 29’32 Chris del Mar (English): I’m Chris del Mar, I am an academic GP, primary care doctor from Australia. I am particularly interested in this particular Cochrane review about anti-virals for influenza because it is such an important review. And we have very few good data on safety and efficacy of these medications. That’s why I am here.
TC 29’55 Marc Jones (English): My name is Marc Jones. I am a biostatistician from the University of Queensland in Australia. As a father of two young children I’d like to know, if they get the flu or any other disease what I should or shouldn’t be giving to them. That’s why I am in this project.
TC 30’19 commentary
Other members of the group are the family doctors Carl Henegan and Matthew Thompson. They are both university professors. Together, they analyzed the published studies on the use of Tamiflu in children.
TC 30’43 Matthew Thompson, doctor and university professor (English)
And we found some surprising things. Firstly we found that there’ve been done really not many studies done in children, so all these decisions on prescribing these drugs to children all round the world are based on seven studies on a few hundred children. And the results weren’t very impressive: We found out that the antiviral seemed to reduce the length of illness of influenza by about a day in children.
TC 31’07 Carl Henegan, doctor and university professor (English)
So that’s, the only benefit we really found was this small reduction in symptoms but then you find the harms. And what we found is in every 20 children you get this additional one of them would vomit on the treatment and so that’s how you weight the benefits…Would you take one day reduction in symptoms but actually you’ve got a 5 percent or one in 20 chance that your child is having some serious vomiting.
TC 31’28 Matthew Thompson, doctor and university professor (English)
These trials – imagine these trials are done on just few hundred children – are not big enough to look at things like hospitalization or pneumonia which are fairly uncommon, fairly uncommon so you need very very big studies to be able to measure these kinds of outcomes and the studies just weren’t big enough to do that.
TC 31’48 commentary
In short, according to Henegan and Thompson’s analysis, it’s better not to give Tamiflu to children. It’s not very effective, we don’t know whether it prevents complications and it carries some risks. For smaller children, a warning had arrived in 2003.
TC 32’06 voice-over (woman) – (English, Roche Dear Doctor Letter 2003)
we wish at this time to emphasize the importance of using Tamiflu only for labeled indications and only in patients 1 year and older.
TC 32’16 commentary
From that moment, it was forbidden to give Tamiflu to children who are less than one year old. A precaution the pandemic made disappear. Fearing the swine flu, health authorities advised even newborns should be given Tamiflu.
TC 32’49 Osaka
TC 32’54 commentary
Doubts on the effect of this drug on younger people are well known to another member of the Cochrane Group, doctor Rokuro Hama, who has been following the events surrounding Roche’s pill ever since it got on the market. This Japanese doctor has the lowest opinion of Tamiflu.
TC 33’15 Rokuro Hama, doctor (Japanese)
I use the expression ‘drug disaster’ for when there is more harm done by the drug than good and when this damage spreads in society due to poor handling by the scientists, manufacturers and regulatory authorities. They could prevent drug disasters. I believe that the Tamiflu is a case of drug disaster.

TC 33’54 Rokuro Hama, epidemiologist and physician (Japanese)
My name is Rokuro Hama. I am the chairperson at Non Profit Organization Japan Institute of Pharmacovigilance. I am also a physician. Here is my staff: Sakaguchi, Kishishita and Umeki.
TC 34’18 Rokuro Hama, epidemiologist and physician (Japanese)
In January 2004 through Roche Chugai announced that Tamiflu should not be used in children under one. This message was disseminated to doctors here in Japan. With this, I thought there must be something big behind this. So I went to look at the evidence used in the approval process of the drug, especially focusing on the animal toxicity tests. I found that 18 baby rats out of 24 had died. Majority of the rats had died suddenly after the first administration of the drug.
TC 35’23 Masako Okada (Japanese)
Masako Okada. I am a mother, and I lost a three-year-old son.
TC Masako Okada (Japanese)
TC 35.31 His name was Keishin. TC 35.46 He was three, so he could talk. He would talk a lot even with adults. He was fun, funny and active child. TC 36.07 I always tried to stay away from giving medication to my child, but I didn’t have much knowledge on influenza. TC 36.22 I didn’t want to give him the drug, TC 36.27 and I still regret having given to him.
TC 36’33 commentary
The child had an influenza-like illness. Keishin took a single dose of Tamiflu Powder.
TC 36.44 Masako Okada (Japanese)
Then he soon fell asleep. I was cleaning next to him, but when I looked at him, he had turned left, the other way, to the wall. TC 36.50 I thought he must be asleep, so I left him alone. And the next time I looked at him, he was facing down, so I got worried if he was able to breathe and when I went to go wake him, he had already gone.
TC 37.36 Rokuro Hama, epidemiologist and physician (Japanese)
Sudden deaths occur when breathing stops. This is when brain activity is strongly suppressed, respiration comes to a stop, leading to death. When brain activity is lightly suppressed, one loses control in his/her behavior, leading to display abnormal behavior. Abnormal behavior and sudden deaths are both caused by the same thing and that is Tamiflu’s effect of suppressing brain activities.
TC 38’18 commentary
The Pediatric Advisory Committee of the U.S. Department of Food and Drug Administration examined the Japanese cases three times, the last one in 2007. There, a FDA officer burst out:

TC 38’35 voice-over (woman) – English FDA Advisory Committee 2007
I was trained as a pediatric infectious disease specialist. Children with high fever have delirium and hallucinations and do some pretty bizarre things sometimes. But I had never seen a child with fever just run out of a room and jump in front of a truck.
TC 38’54 commentary
A year later, the full data-set of Kaiser study is not available yet. Even though in December 2009, on the columns of the British Medical Journal, Roche had promised to make them public.
TC 39’11 Tom Jefferson, epidemiologist Cochrane Collaboration (Italian)
What Roche gave us was not what they had promised. They had promised to give us the complete studies, the full trial reports.Those are the exact words they published on the BMJ.
TC 39’28 commentary
A complete study, or full trial report, is made up of 4 or 5 so-called “modules”. Until now, Roche gave the Cochrane Group only one single module for each study that was part of Kaiser’s review. That’s not enough to calculate Tamiflu’s effectiveness on the complications of influenza.
TC 39’53 Stephen Toovey, Tamiflu Team, Roche (English)
Roche actually reached out to the Cochrane collaboration to try and understand what it is that they wanted. And Roche subsequently made 3200 pages of data available to the Cochrane group, and we really thought that that would have answered their questions.
TC 40’10 journalist RSI (woman) (English)
But Roche has sent to Cochrane collaboration group only 1 module of the 4 or 5 available. So, the question is still to get what was promised in December 2009.
TC 40’22 Stephen Toovey, Tamiflu Team, Roche (English)
well, Roche has already made 3200 pages of date available, and probably the reassurance that your viewers require, is that all those data is available to health authorities around the world.
TC 40’40 commentary
That’s true, authorities have received much more data than Cochrane’s scientists. From the documents of Food and Drug Administration, which are public, we find out that when they had to approve Tamiflu, they received tens of thousands of pages. Yes, that’s right, tens of thousands. One can legitimately ask oneself: “Where will health officers find the time to read all this stuff, considering that every year they have to examine so many new drugs that are still waiting for the necessary approval to be sold on the market?”

TC 41’10 Fiona Godlee, editor in chief British Medical Journal (English)
They have such a vast amount to look at and there is this new phrase called swamping bias which is a bias introduced by the fact that the company now will give them a huge amount of documentation saying: Here you are, everything you need. But they don’t have the resources to evaluate these properly.
TC 41’28 commentary
Oh well, our health officers need to have great skills in order to correctly choose what to read and what to give priority to. if not fairly impossible. Prominent pharmacologist Garattini was part of the committee that authorized Tamiflu to the European Union market. He remembers the incredible amount of material they received and, most of all, professor Garattini recalls how doubtful the Committee was.
TC 41’54 Silvio Garattini, pharmacologist Mario Negri Institute (Italian)
We can say that there was never a strong conviction that this drug was a revolutionary one. When it was cleared for sale on the European market, there weren’t available very strong evidences. It was about sparing the patient one day of Influenza’s symptoms duration on an average duration of 5 or 6 days. Moreover, the drug seemed to have some relevant side-effects.
TC 42’30 commentary
So, how is it possible that, despite all these doubts, Tamiflu became a public health medication ? The World Health Organization played a key role. Since 1999, the WHO began pondering the strategies that would allow the world to fight an influenza epidemic.The first guidelines were published in 2004 thanks to some very peculiar advisors like ESWI, a network of influenza experts funded by the pharmaceutical industry.
TC 43’03 And like a number of specialists who, oddly enough, are in both the WHO Advisory Committees and are listed as advocate speakers in the Tamiflu’s promotional leaflets, published by Roche in the 1990s. These “consultants” are the so called “key opinion leaders”.
TC 43’22 Stephen Toovey, Tamiflu Team, Roche (English)
A Key Opinion Leader is somebody who is an expert, a leading top doctor top scientist in their field, and the role of these people is to help us all. So they have a role in advising Roche, because Roche’s role is to develop new medicines so they help us with that.
TC 43’41 commentary
One of Roche’s most appreciated expert is Professor Frederick Hayden. He signed several studies as a Roche consultant, including Kaiser’s research on the complications of influenza. It was Hayden who wrote as WHO consultant the first guidelines that suggested governments stockpiled anti-viral drugs such as Tamiflu in the occurrence of an influenza pandemic.

TC 44’07 Charles Penn (English)
My name is Charles Penn, I am a scientist here in the Global Influenza Program at the World Health Organization.
TC 44’19 Charles Penn WHO (English)
We need, to do our job properly, to consult with the people who have the best expertise and can give us the best advice in the world. We have a process, a robust a rigorous process here for insuring that the advice we get is impartial and balanced. So we ask our consultants to tell us about their wider interests through a standard process what we call declaration of interest and we asses that information and that interest.
TC 44’55 journalist RSI (woman) (English)
Looking back is not a big issue that Professor Haydn was consultant – at the same time! – for Roche and WHO?
TC TC 45’03 Charles Penn, WHO (English)
Well, as I’ve said, it is a fact of life that the most expert people in the world are, their advice is sought by many organizations and if we want to access the best advice we have to accept that.
Journalist RSI (woman) (English)
I see.
TC 45’22 commentary
It appears obvious, though, that such a “double role” could produce a conflict of interests. According to our investigation, Tamiflu’s turning point took place a short while after the WHO published those guidelines. Summer of 2005, planet Earth is right in the middle of the avian flu scare.
TC 45’44 In August, the media announced that Roche would donate WHO three million doses of Tamiflu to supply poorest countries.The news spread commotion.
TC 45’54 In Basel, in the meantime, Roche received a very important phone call, one that would change the history of the drug. We find a scent of it in a case study published by INSEAD, a French business school. For the tomorrow’ leaders, a Roche manager recalled:
TC 46’10 I could not believe what i was hearing. The CEO of our US organisation had been asked by the US government about our ability to supply 200 milions courses of treatment of Tamiflu.
TC 46’24 George W. Bush: we have to act now, later would be too late (English)
TC 46’36 Back then, uncovering that the Secretary of Defense, Donald Rumsfeld, had personal interests in the affair appeared sort of baffling. Rumsfeld had been the director of Gilead, the company that had discovered Tamiflu, and is still today one of their most important shareholders. Financial journal Fortune calculated that, thanks to the avian flu, Rumsfeld earned one million dollars.
TC 47’05 Since 2006, Roche has hugely increased the production capability. As shown by a document we found on the internet, by the end of the avian flu alert, Roche had become capable of producing hundreds of millions of doses a year. When the swine flu alert came about, Roche was ready to meet governments’ requests.
TC 47’32 Silvio Garattini, pharmacologist Mario Negri Institute (Italian)
The WHO has raised an overplayed alert towards the H1N1 flu. And so governments, since the World Health Organization is such an authoritative source, felt compelled to follow its advice and buy the drugs and the vaccines WHO recommended to be prepared for what looked like it would become a serious problem, but that in the end revealed itself to be an even smaller problem than the seasonal flu.
TC 48’10 commentary
The WHO even recommended the prophylactic use of antivirals: to prevent the infection.
TC 48’21 Laurent Kaiser, virologist (French)
There is no rationale for the general population to get Tamiflu as a preventive treatment. I had never foreseen that my study would have been so extensively cited, even mis-cited and for sure cited out of context, to justify the use of Tamiflu and to buy millions of doses of this drug during the 2009 pandemic in England.
TC 48’53 commentary
The English government took the radical path, and opened up a “swine flu” hotline for its citizens. The consequences for some patients were devastating.
TC 49’08 Deborah Van Horenbeeck, Samantha Millard’s Mother (English)
TC 49’33 She was a 18 year old girl, perfectly healthy, nothing wrong with her, all she could have done was go to bed and just done her off. TC 49’44 The hotline was, if you had flu-like symptoms you phoned up the swine flu line and then you were asked a lot of questions and you answered these questions. Apparently if you ticked so many boxes than you had swine flu.
TC 50’04 Samantha Millard (English)
So I phoned up the number and it was the swine flu number and they said what are your symptoms and I said I have a running nose, earache and my temperature is a little bit high and I said but it’s normal? And they said: You’ve got the swine flu and you need to take these tablets. I’ve said to mum, thinking about, how can they know over the phone if you have the swine flu.
TC 50’36 TESTO
A diagnosis by phone and a remote prescription for Tamiflu. Samantha’s mother rushed to the pharmacy to get Tamiflu. And gave it to her daughter. It was the beginning of a nightmare.

TC 50’53 Deborah Van Horenbeeck, Samantha Millard’s mother (English)
She had two tablets and in the following day she’ taken one, by the afternoon she’d a rash over the chest, a red rash and her cheeks were flushed red. When I came back into the front room to check on her and she’d got a big blister on her lip and phoned the doctors straight away, said look now she’s got blisters and they said bring her straight down. By the Saturday she was put into a coma and on lungs pump machine, intensive care and then it just went worse. She blistered the whole of her outside body, down the throat, in the lungs, her eyes, her legs, her hands and that was like a roller coaster. We just didn’t know if she would survive and neither did the doctors.
TC 51’56 Samantha Millard (English)
And then next thing I remember I was waking up in hospital and mum telling me I had nearly died. That’s the next thing I remember and I can remember hallucinations I had when I woke up which were awful and then I slowly started losing my eyesight. I haven’t got pictures anymore, I can’t look at my own, it’s just weird.
TC 52’28 Deborah Van Horenbeeck, Samantha Millard’s mother (English)
Roche declared they’re going to investigate Samantha’s case. I’ve heard absolutely nothing from Roche, I’ve had no correspondence, I’ve not even had a letter saying we are looking into your daughter’s case, they don’t care.
TC 52’52 journalist RSI (woman) (English)
Roche had promised that would have investigated the case. Her family claims that you never contacted them. Is this true, did you contact the family of Samantha Millard ?
TC 53’01 Stephen Toovey, Roche Tamiflu Team (English)
Well this is obviously a very upsetting case and when we something like this happens one have always sympathy for the patients and for the families, it is Roche’s position and in fact Roche’s obligation by law, to investigate all the adverse events and to report them to the health authorities.
TC 53’23 commentary
Samantha Millard was hit by the Stevens-Johnson Syndrome, a rare, very rare syndrome that has been nonetheless pointed out by Food and Drug Administration as a potential side-effect of Tamiflu.
TC 53’32 This rare but serious side-effect is not listed among the other side-effects of Tamiflu in the Swiss patient information leaflet. Swissmedic, the federal authority for drug safety, states that such cases have never been reported in Switzerland.
TC 53’55 According to the WHO, pandemics gave evidences on Tamiflu effectiveness. Roche agrees.
TC 54’05 Stephen Toovey, Tamiflu Team, Roche (English)
Independent scientists and doctors, around the world argentina, America, European countries, across the world to china, all they came out with the same findings, they found that tamiflu kept the people out of hospital, reduced the number of deaths, today we have parents and children united, they would not be united if it hadn’t been for this drug. So the evidence speaks for itself, it is a safe and effective drug.
TC 54’47 journalist RSI (woman) (Italian)
We have been told that the important thing is that during the H1N1 pandemic, Tamiflu has been reported to be effective on the flu’s complications.
TC 54’57 Silvio Garattini, pharmacologist Mario Negri Institute (Italian)
But the question is: how it has been reported? It has been reported by gathering random data, without any scientific study. We still need studies to prove this drug effectiveness.
TC 55’17 Fiona Godlee, editor in chief British Medical Journal (English)
I think this story of Tamiflu is quite iconic, because it is a public health drug, lot of money spent and quite extreme lack of transparency. But I think it’s unlikely to be unique. The whole of the process by which we evaluate drugs and publish researching journals is deeply flawed and we cannot ignore this anymore, we have to find better ways to test drugs and to make the information about drugs publicly available.
TC 55’44 Tom Jefferson, epidemiologist Cochrane Collaboration (Italian)
Tamiflu’s affair has taught me that very often what I see is not what it seems. Since I have a responsibility towards my patients I need to be cautious, I must not get too enthusiastic, I must not listen to the key opinion leaders, who, in many cases, have been created by communication agencies, and I must use my own judgement.
TC 56’19
camera Angela Meschini, Harry Häner. Sound Diether Hell, Lilly Gurzeler. Editing Gerardo Wuthier. Collaborators: Carlo Zoppi, Nicole Hayoz, Igor Hammer, Elena Luzio, Ayumi Kodama, Mari Yamauchi Neuenschwander, Erika Bardakci. Thanks: NPR, CBC, Chukyo TV, Chiaki Kasai, INSEAD, Vreneli e George Baumgartner.
TC 56’36 last frame.