Camera: Tristano Montorfani, A. Meschini, F. Pedrozzi, N. Viglezio.
Suono: L. Barison, M. Villa, G. Vanzetta, A. Rosa.
Montaggio: Mauro Triani.
Sonorizzazione: Andrea Belloni.
Ha collaborato: Michele Galfetti, Barbara Jenni.

OFF from the diary of Mauro Weick
“At night, I do sleep, but it’s a restless sleep – I wake up very tired – I have strong headaches, nausea and feel confused” “I feel a strong repulsion for everybody – and everything” “definitely, a terrible suffering”.

Michael Papantonio, lawyer
The interesting thing about this drug it’s that it was never intended for something like clearing up pimples. This was a drug that was intended for chemotherapy. Roche could not make enough money with it just with chemotherapy, so they said: Let’s expand it. Let’s sell it to more people. And they ended up selling it to people with acne.

Chloé (Geneva)
Yes I said, I am sure that this is due to Roaccutan, but the lady, the psychiatrist she said : No it didn’t happen instantly, it happened six months later, she said I was a depressive. That’s how I was labeled.

Karin K.
After the nightmar,e you have to go through hell of psychiatry. Because there it is also the drugs : psychotrope, neuroleptic, antidepressants, all these drugs with the adverse reactions.

Liam Grant
In February 1997 Liam started a 4-month course of treatment on Roaccutane. He had very mild acne. He was diagnosed 2 on a scale of 0 to 10 - he had a 4 month course which he had to do, which he was due to finish on June 20th. He died on June 15th. So at that point he had only got another few days of the course to finish.

Title:
"Morire per la pelle" (to die for the skin) di Serena Tinari and Harry Häner

Liam Grant
He became gradually more and more withdrawn, he spent a great amount
of time in his room and he started circulating less with his friends. In the month of May there was brightness and sunshine and he’d come out and he’d say that this was giving him terrible headaches and he wanted to stay inside. But still, we didn’t know, we never associated the drug with it because as far as we were concerned this Roaccutane was very simple, ordinary medication, a bit more than a cream, but that’s it.

Chloé (Geneva)
It was in April, I was on my bike and I wanted to throw myself under a car, I didn’t talk to my mother, right away she took me to a dermatologist and the dermatologist said no, no, it isn’t serious, but let’s stop it, then.
From then on, it got slowly worse. I started to not sleep, feel bad, deprime myself, isolate myself at school.

Karin K.
In the evening at six she had a crisis I was really desperate, I didn’t know what to do, she started to panic saying Mummy, I will die, I comforted her and at the same time I made an emergency call. With the help of the emergency doctor, we took her to the emergeny room of psychiatrics of the hospital of the canton of Geneva.

Chloé (Geneva)
They put me into a locked ward, in other words visually said in quarantine, you don’t see the light. I found myself there wearing an hospital suit. I was scared: I said to myself, I will be interned lifetime.

TEXT
Devastating side effects. The adverse reactions are reported to the authorities by the doctors and putted in the database of the World Health Organization. Since 1983 to nowaday, the database contains 2000 depression, 1000 between attempted and committed suicide, and all together over 6000 psychiatric adverse events related to Roaccutan. These figures should be multiplicated for 100, according to US health authorities. Because only about 1 % of adverse reactions would be reported. According to the figures, Roaccutan is provoking a massacre.

It’s called isotretinoin. Indication: cystic severe acne, resistant to other therapies. Since 4 years, generics are also available on the market.
Roaccutan is well known to cause heavy birth defects since its marketing, in 1982.
In US, the Congress have been discussing about it. The spin came from a congressman. His own son killed himself with 17.

Bart Stupak, congressman
My son went on Accutane in December 1999 and on May 14th, about 5 and a half months later he shot himself while on Accutane. This was completely out of characteristic of my son. He was a young man who loved life. He’d light up this room if he walked in right now. So after some time my wife just thought that maybe there could be some relation between Accutane and his suicide. I found that hard to believe: why would an acne medicine lead to disturbed thoughts or depression. We found that the FDA, the Food and Drug Administration here, in the United States, filed a warning in 1998. We had no knowledge of that. My first question was: why don’t people know about this? Secondly, why would the FDA in 1998 put a warning note, but not tell people? And what led to the warning. Why the warning?

TEXT
Stupak obtained two Congressional hearings, in 2000 and 2002.
The results? Astonishing.
Confidential papers made available by the Commission show that Roche employees where shaking each other hands, because they managed to delay the intervention of regulatory authorities. The “Roaccutan team” wrote: Please try to celebrate: no registry for psychiatric adverse events.

TEXT
Father becoming paladins. Liam Grant doesn’t give up. The Irish is a financial detective - he starts investigating Roaccutan. He founds a website with information about the drug.

Liam Grant
There was absolutely no explanation as to how he could have done this. Somebody like him who was so outgoing and had so many interests and so on. And that’s how my investigation started. I decided to engage a full-time scientist for a period of 6 to 8 months, investigate this, see what comes out of it and write a report.

TEXT
The researcher found dozens of studies on the issue. Some of them put between 1 and 5 % the patients that would develop depression. The figure of reported suicides? The comparison with the other acne medications is striking.

Liam Grant
Because there were so many studies linking the drug, the question I asked was: what else can be done to either prove or disprove the relationship. I spent two years trying to get organisations, dermatologists, to do these studies and none of them would do it. Even though I argued: Look this is going to prove it or from your point of view it will disprove it, so why don’t you do the studies? They never did it. About two years later I decided I’d have to do it myself.

TEXT
Liam Grant gives an amount of money to a prestigious American university, so that a study with the PET brain scan can be realized. Emory University, Atlanta, Georgia. Doctor Bremner is an expert, known all over the world.

J. Douglas Bremner, psychiatrist
We looked at a group of 13 individuals who were treated with isotretinoin, which is Accutane in the United States, and compared it to 15 individuals who were treated with antibiotics. And we looked at brain function before and after treatment, with antibiotic or isotretinoin. And we found 16% decrease in brain function over the frontal cortex, which is the brain region involved in emotion and mood, in the patients
treated with isotretinoin, but not in the patients treated with antibiotic.

TEXT
Bern. We went to ask about that to a Swiss expert. Konrad Michel is head of the psychiatric departement at the University clinic.

Konrad Michel, psychiatrist
This is a single study with a small number of patients. The results are anyway impressing. The researchteam is an established team of Dr. Bremner and Charles Nemerov as senior authors, published in the American journal of psychatry as a famous journal. It is clear that this is a finding which matches the findings about depression and suicide .
For our clinical practice this study means that we do increasingly pay attention to the use of Roaccutan in young people, that we got used to ask regularly this people when entering, also ambulant patients, if this drug has been taken by them. We do believe that this makes sense as a precaution.

TEXT
In Bern, psychiatrists look like taking for serious the Bremner study.
Indeed, Roche argues: the causal relationship between Roaccutan and psychiatric side effects has not been proven. Bremner study? Roche refused to participate.

J. Douglas Bremner, psychiatrist
I asked if they’d be interested in providing medication or other support for the study and they weren’t interested. Well, often times companies will give, provide free medication. I’ve done that all the time. They may not fund a study, but if you request, they’ll provide free medication. So, I was surprised that they were not interested in providing even the medication.

TEXT
In US, attorney Mike Papantonio fought and won in the most important litigations against Big Pharma for product liability. Today, he’s working on Roaccutan. We met him in New York – and he’s not surprised at all, by Roche’s attitude.

Mike Papantonio, lawyer
If you, today, were to ask Roche: Explain to me what is the mechanism, the bio mechanism of this drug. You know what? They wouldn’t be able to tell you. They don’t know. This drug has been on the market since 1982 and they have not spent one dime, not one single dime, trying to figure out how it works, how it goes about causing these side effects.

TEXT
Mrs Karin called up Roche and talked to the marketing director in Basel.

Karin K.
The gentleman was very nice, he explained to me : Madam, this is a drug which is a derivative of vitamin A. Because I insisted I want more information. If you take vitamin A, there is no harm. But with this derivative, it happens, these suicidial thoughts. I said : Why ? He said to me: we don’t know, we don’t know. But I was very very curious, I said, this is not possible, a company, known worldwide, launches a drug and you don’t know, the scientists don’t know why it causes these effects ?!

TEXT
The swiss patient information states: the mechanism have not been established. Few lines for the problem. Something more is to be found in the label for the health professionals. But by the quantity and the quality, absolutely nothing to compare with the US label. We went to ask for explanations to Swissmedic, the Swiss federal authority who controls the drug safety in Switzerland.

Andres Schneider, Swissmedic
Yes, in terms of amplitude there is a big difference, this here is the american one and this is ours. We are about a fourth as ample. The difference consists in the detailedness of the specifications. The american information contains almost everything, also about the studies, even the methodology of the studies is described, studies about animal testing are also included. At ours – we usually do without such specifications and get directly to the problems. Say: here are the risks, there you must be careful.

TEXT
But let’s have together a closer look to this difference. In the US label, the absolute forbid to assume Roaccutan during a pregnancy, have a great evidence. But what strikes, is the detailed list of symptoms.
TC 00.

VOICE OFF
Stop taking the medication and call right away the doctor if you start to feel sad or have crying spell, lose interest in activities you once enjoyed, have trouble concentrating, withdraw from your friends or family, have feelings of worthlessness or guilt, start seeing or hearing things that are not real.

TC 00.
Journalist
Would'nt such a list also be useful for swiss doctors?

Andres Schneider, Swissmedic
We simply assume, that the doctors have personal responsibility. They are specialists, who have the information either in their head or they know where to find it.

Karin K.
I called the dermatologist and asked for an explanation. You know all these things. My daughter has told you. But you know your daughter didn’t have any sign of depression. I said yes, because my daughter isn’t depressive. And the, he adds: there is nothing written about Roaccutan dangers in any litterature. I said: What, are you kidding me ?!

Journalist
We detected that many dermatologists have the tendency to tell their patients that there is surely no relation between the taking of Isotretinoin and depression. Are you worried about that?

Andres Schneider, Swissmedic
Yes, because it does not accord to what we write in the label. We did see it, for exemple, after we issued the information to the pharmacists about the prescribing restrictions to women. We did receive some feedback that they hadn’t known about this before. So probably there are actions needed and we will take some more measures to make the information better.

TEXT
While Swissmedic thinks about it, the Health Department of the Swiss state Ticino decided to take action. First in the country, the Swiss canton is going to send to dermatologists and psychiatrists a questionnaire, to understand better what do they know about Roaccutan. Together, a fat documentation, with the report figures and the published researches, will be sent to them all.

Patrizia Pesenti, Health minister of Ticino
The goal is to improve the information. We’re only going to collect data, about the present situation. But afterwards, scientifical studies are needed, which should assess the relationship between this drug and the psychiatric adverse events. It is very important that these studies are completely independent. They must be independent. And when I say independent, I mean independent from the pharma industry.

TEXT
September 2006. Bath University, in England, and Texas University published together a new, independent study about Roaccutan. We went to Austin, Texas, to meet and interview the professor Michelle Lane, who did realize it.

Michelle Lane, researcher
So what we did was we took two groups of mice. Mice were adolescent, and one group of mice received an injection of the drug at the same dose that’s given to human patients. Another group of mice just received an injection. And the mice received either just an injection or just the drug for six weeks. And at the end of the 6 weeks the mice were put through a variety of behavioral tests and these are really commonly used tests - they’re actually used to study antidepressants. The attempt of these tests is to model what is happening in humans, but of course a mouse isn’t a human and you can’t ask a mouse: Are you sad? You can measure this lack of desire to escape from a bad situation and that is, in theory, related to a human being’s lack of motivation in depression. So the results of our research were that in adolescent mice the same dose of Accutane that’s given to humans causes an increase in this depression-related behavior.

TEXT
Michelle Lanes study made the One on the international media. Headline: “That’s the scientifical evidence of the link between Roaccutan and depression”.
What about the Swiss media? They simply ignored it.
But in the same days, they were actually reporting about Roche: there was the Open door day in the Basel headquarters. Open doors to everybody - but please, no inconvenient questions: to our request to comment the latest studies, the company's doors stay locked. Roche wrote us: our position didn’t change and we don't wish to participate to your program.

(PAUSE)
TC 00.
But this drug, how much - and How – has it been tested? In the documents given to the regulatory authorities for the marketing approval, even not one case of depression was reported.
After 20 years, in Switzerland, the parents of a boy who took Roaccutan before the marketing, decided to come out.

Heinz Weick
He was the kind of son that every parent wish to have. He was hot for his studies, was outgoing and funny. He was thinking about ecoming a journalist – or something like that he would have liked it. Mauro had acne so he started to get cured by a dermatologist, director in a big hospital, in august 1979. In January 1981 the dermatologist called me and proposed a new treatment, which was already tested in US and promised miracles.

TEXT
Doctor Gilliet prescribes Roaccutan to Mauro Weick. Two courses, between 81 and 83. The drug was still in the clinical test phase. After one year..

Heinz Weick
He called me in his office room and told me Dad, I can’t connect my brain anymore. I don’t understand when people are talking to me, I’m in a big confusion.

From the diary of Mauro Weick
I can’t concentrate myself, on anything. The meaning of words and sentences is kind of escaping from me, as it would be unstable or superficial. Even simple logical concepts make me desperate, because I can’t understand them.

Heinz Weick
In august 85 we luckily found a psychiatrist. After one month, he called me up and said Look, I can’t find any psychiatric disturbances in your son. Something is missing in the picture, he said. And organized a date with prof. Mumenthaler, in Bern. He was a famous neurologist, one of the best on a world scale at that time.

TEXT
Prof Mumenthaler couldn’t clear the case. The psychiatrist sent the boy to another neurologist, who suggested him to go in a clinic.

Heinz Weick
He came back home desperately crying, was difficult to cool him down. He said: I don’t want to land in the head-shrinker's hands. He was afraid to be locked for weeks and months in a psychiatric hospital.

TEXT
Mauro holds up: he inscribes himself at Pavia university, in Italy, to continue hist studies. In July 1987..

Heinz Weick
According to the police, Mauro left Pavia early in the morning, but instead of coming home, where my wife was ironing, Mauro continued to the highway and reached the highest bridge. He wrote a letter with in big letters “Help”, sticked it on the car glass with the tape he bought before, and jumped down.

Heinz Weick
In 1998, I’ve been reading on two newspapers a very small article, big like two stamps, about the dangers of Roaccutan. But was small like that (makes the sign with the hands). I immediately wrote a letter to doctor Gilliet. He was very kind, gave me a date and in the meanwhile sent me a letter, letting me understand that there was absolutely no problem. Actually, when I went to visit him he said No, take it easy. He convinced me, and today I got it: he treated me like an idiot.

TEXT
In 2005, the Weick family see a TV reporting about Roaccutan. The man, former director of a private health insurance, today retired, decide to investigate. And found out many - and sad - surprises.

In 1998, the dermatologist dr Gilliet told him Take it easy. But in the meanwhile, he reported the case as "suspected suicide linked to Roaccutan" to the health authorities and to Roche. He wrote also a letter to a colleague based in Geneva:
TC 00. MALE VOICE
“3 of my patients committed suicide".
“One of them is the son of a high ranked officer of an health insurance - I can expect legal consequences and that's why I try to clear the best I can this issue"

Roche attorneys write to mister Weick:
TC 00. MALE VOICE
“We couldn’t find any document related to your son in our database. In 1998, the suicide of him was anyway reported to us”.

But Mauro Weick, was him participating to a clinical study - or not?

We asked for an interview to doctor Gilliet, but he preferred to answer to some written questions. Gilliet confirms: it was a clinical study, but he "can't recall the details". But he's happy to specify: in my medical dossier about this boy I can read the following line: 19 January 1983, sent formular to Basel".

TEXT
Where are the documentes of the Weick case? The company, wich at the time was the only and one authorized to produce and distribute the drug for clinical tests, states to have no one single paper about him.
But in the mistery, one we got for sure: since 1998, Roche knew that one of the patients, who took the drug before the marketing, killed himself.

But what the hell are the regulatory authorities doing? Like Roche, also Food and drug administration declined our interview request.

J. Douglas Bremner, psychiatrist
You can calculate that it takes 800 patients in order to have an adequate trial. And, you know, I’ve asked the FDA if they would request Roche to just provide the medication for a trial like that. And they told me that they don’t have the power to do that. I mean, if they don’t have the power to do that, then who does!

TEXT
Well, what's the power of the health authorities towards Big Pharma?
Let's have a look to a concrete example. The Canadian authorities issued a warning: Roaccutan may cause infarction and brain ictus. Swissmedic received reports of 10 cases -and one dead patient.

Andres Schneider, Swissmedic
It can be that under influence of Isotretinoin the risk increases. We do not know it yet, we have requested information from the company, a statement about these cardiovascular problems and as soon as we have it, we will have a close look at it. The request was made during this summer.

TC 00.
Journalist
But you wrote us that you already did that eight months before that Canadian adverse reactions newsletters, didn’t you?

TC 00.
Andres Schneider, Swissmedic
Yes.

TC 00.
Journalist
That was before april 2006, so that means the summer before, right? So during summer of last year you requested that information from the company?

TC 00.
Andres Schneider, Swissmedic
We then asked for information and now we are again in touch with them.

TC 00.
Journalist
So that makes now a year and a half, right?

TC 00.
Andres Schneider, Swissmedic
For the current request, yes.

TEXT
Well, beside the power of writing letters, the regulatory authorities does'nt look like having a big power towards Big Pharma. But how many adverse events are linked to Roaccutan?

Mike Papantonio, lawyer
You have 152, about 152 side effects. We’re not talking about a drug that cures heart disease or cures cancer. People would never make the choice to use this drug. Never. Once they understand how dangerous it is, there’s no logic, there’s no reasoning person that would say: I’m going to take Accutane to clear up pimples.

TEXT
Considering the risks, all over the world the regulatory authorities decided that Roaccutan could be prescribed only for severe cystic acne. Indeed, it is commonly given also for mild and middle acne. It happened to Chelsea. We met her in Oregon. Chelsea developed an ulcerative colitis, a degenerative intestine sickness. That's why she sued Roche.

Mother of Chelsea
There were some really really bad moments, a lot of pain was happening to her, she spent a lot of time in the bathroom and she would yell for me and I was going and sit with her, and I would see all the blood that would come out, and the tissue, and I would just hold her hand, and she just had some times she said I wished, Mom, I wasn’t alive.

Chelsea
I feel like I’ve been rubbed in certain areas, because I’m uncomfortable being in certain situations being around people, I am angry because I’m in pain and I don’t want this, it’s basically gonna be like that the rest of my life, and I do have to watch, you know, I need to take my medicine, do certain things I don’t want to do, like colonoscopy, I don’t want to do that, and when I do have my bad flare ups there are certain medicines I need to take, I don’t want to do that because they make me sick, do certain things that I don’t want but I have to.

Mother of Chelsea
I am angry. Because she was a fine, healthy, nothing wrong teenager, before she took Accutane.

TEXT
But the biggest number of reports is about psychiatric adverse events. In the Swiss database, they represent the 19 % - equal to 56 psychiatric events and 6 committed suicides. Often the onset of symptoms comes many months after the medication was stopped.

J. Douglas Bremner, psychiatrist
The effect is through protein transcription, that would imply that the effects would take longer to come on, but also would take longer to go away. Because, once you’ve started affecting protein transcription, you’re basically talking about changing the structure of the brain. It could take weeks to refer back to normal. It’s possible that some individuals would just stay that way.
There will continue to be cases of suicide and depression. You know, Roche may continue to argue that they’re not related, that suicide is common or that there’s other extenuating circumstances. However, the science won’t stop. There’s even a new study that came out, it increases oxidative stress and causes DNA damage. So, I don’t think that… I think that most people would think twice about taking a drug that causes DNA damage. I mean, I certainly would.

TEXT
And the justice too, won't stop. Because the controversy is scientifical, but it's in court that the play is done. For health damages caused by Roaccutan, only in US there are currently 400 litigations - they'll be a 1000 before the end of 2007.
But also on this point, Roche doesn’t wish to issue any statement.
In Florida is currently taking place the trial for the Bishop case. Charles Bishop, 15 years old, crashed with a small airplane in a skyscraper in Tampa. He was taking Roaccutan, too. The Court asked Roche to provide studies and figures, the dilatory tactics of the Swiss company offended the Court, who felt to be "misled". The Judge ordered Roche to bring all the papers to US.
Doctor Bremner too, is involved in the trials. Roche submitted numerous subpoenas to the Court about him.

J. Douglas Bremner, psychiatrist
I have in fact decreased the amount of research that I do on this topic just because not only is it hard to get anything done in that kind of environment and I’m just tired of answering the subpoenas.

Journalist
Do you feel under pressure by Roche?

J. Douglas Bremner, psychiatrist
Yeah, I feel a lot of pressure. They’ve attacked my credibility and gone into personal areas, and done things that are really irrelevant to the question, which is the question about the effects of Accutane in depression. So, yeah, I mean, they’ve basically ruined the last year of my life.

TEXT
Liam Grant too, is seeking for justice in Court. The supreme Irish court is due to make a decision soon. In the meanwhile, Roche sent him a letter and offer to pay him all the damages and costs, if he retires himself from the litigation. Total amount: about one million dollars.

Liam Grant
Why do they want to buy me off? Because they do not want to come into that venue, the court venue, where they and I are equal. Because in a court of law you don’t have a public relations person and everything you say is subject to scrutiny. Roche don’t come on programmes, I’ve been on numerous programmes and they will not come on programmes and will not send representatives to debate the issues. But they will have to in a court of law. That’s the first thing. And secondly, my attitude is: small bites. You know, how do you bring an elephant to its knees? Small bites.

Heinz Weick
I want to make a call up. Is there anybody who took Roaccutan? Who suffered like my son Mauro have been suffering? There are maybe there parents who lost a son or a daughter thanks to this drug? I want to invite them all to stand up and come out - put beside the shame. Because we need badly to collect data, which can force the authorities to do finally something, take action to avoid similar tragedies.