CAUSE OF DEATH: UNKNOWN – Big Pharma & the selling of m… — Transcript

A personal investigation into the pharmaceutical industry's role in mental illness treatment and the mysterious death of the filmmaker's sister.

Key Takeaways

  • Antipsychotic medications can have fatal side effects that are underreported and underestimated.
  • Pharmaceutical companies prioritize profit, often at the expense of patient safety and transparency.
  • Mental illness treatment is heavily influenced by aggressive marketing strategies targeting non-specialist doctors.
  • Regulatory warnings about drug risks often come too late, after significant harm has occurred.
  • Public awareness and scrutiny of Big Pharma's practices are crucial for safer mental health care.

Summary

  • The filmmaker investigates the mysterious death of his sister Renate, who was a psychiatric patient on multiple antipsychotic medications.
  • Renate died at age 35 with an unknown cause of death, while taking high doses of antipsychotic drugs.
  • Warnings about sudden death linked to these antipsychotics were added two years after her death, contradicting her psychiatrist's claims.
  • Only a small percentage of serious side effects from antipsychotics are reported, suggesting actual death numbers could be much higher.
  • Antipsychotic drugs can cause cardiac changes, potentially leading to sudden death, especially when multiple drugs are combined.
  • Leaked internal documents about Zyprexa revealed the pharmaceutical industry's focus on profit over patient safety.
  • Eli Lilly aggressively marketed Zyprexa to primary care physicians, despite it being approved only for schizophrenia and bipolar disorder.
  • The company faced over $1.6 billion in fines for hiding dangerous side effects and illegal off-label marketing practices.
  • The film critiques Big Pharma's control over mental illness diagnosis and treatment, highlighting systemic issues in the industry.
  • The filmmaker emphasizes the need for public awareness about the risks and ethical concerns surrounding psychiatric medications.

Full Transcript — Download SRT & Markdown

00:24
Speaker A
These rings belonged to my sister Renate. She was wearing them when she died at only 35.
00:32
Speaker A
The cause of her death was unknown. Ten years ago, I began this film to find out what led to my sister's mysterious death.
00:46
Speaker A
But I had no idea it would lead me to an investigation of the pharmaceutical industry and its matrix of control over our society.
01:01
Speaker A
It's been like putting together pieces of a jigsaw puzzle without knowing what the finished picture would look like.
01:12
Speaker A
Now that I've seen the big picture, it's vital that you do too. I wonder—how much is a human life worth?
02:20
Speaker A
Renate was only 34 years old when she died. The day after her body was found, I went to her room filming the things she left behind.
02:45
Speaker A
It was an unconscious act. My last chance to hold on to her. She died while she was in kind of an institution where they took care of her because she was a psychiatric patient.
03:23
Speaker A
She was schizophrenic. And what I want to find out in this film is... what was it that caused her death?
03:44
Speaker A
What was it that caused her to suddenly just fall over at 35 years old?
04:07
Speaker A
We were three sisters. Renate was 10 years older than me. As a child, I used to call her “Dadya,” but after I began working on this film, I had to start calling her by her real name.
04:33
Speaker A
But to me, she will always be my Dadya. At the time of Renate's death, she was taking five different medicines in high dosages that had been prescribed by her psychiatrist.
05:04
Speaker A
I asked the psychiatrist if they could have caused her death. He told me that was not possible.
05:23
Speaker A
I began researching to learn more about the medicines he treated Renate with. The antipsychotics.
05:34
Speaker A
The first generation of antipsychotics arrived in the late 50s. In the 90s, a second generation of antipsychotics were launched.
05:44
Speaker A
These included Risperdal from Johnson & Johnson, Seroquel from AstraZeneca, Zyprexa from Lilly, Geodon from Pfizer, and Abilify from Otsuka.
05:56
Speaker A
During the 2000s, they became some of the most sold drugs in the world. I discovered that two years after Renate’s death, a warning of sudden death was added to the label of all the antipsychotics she was being treated with.
06:24
Speaker A
Sudden death. Renate’s psychiatrist told me there are no reported deaths from antipsychotics. But that's not true.
06:45
Speaker A
I found a list of 126 deaths. I met with Kirsten Myhr who handles and assesses reports of suspected side effects to the Norwegian authorities.
06:56
Speaker A
What percentage of side effects are being reported? Less than 5% of the serious side effects.
07:05
Speaker A
It's always been like that, it hasn't gotten better, and I don't think it will regardless of which system we use.
07:14
Speaker A
So if I'm trying to find out how many there were where antipsychotics were a contributing factor, do you think I'll have trouble finding the actual number?
07:28
Speaker A
Yes, these numbers are what everybody uses, but there is no reason to believe that this is more reported than other side effects. On the contrary, in fact.
07:41
Speaker A
So if you multiply that number by 20, you might get something close to the real number.
07:45
Speaker A
If we say 5% are reported. There are 126 reports, so it could be 2,500.
07:58
Speaker A
Not 126. I see. 2,500 in Norway? Yes. Possibly. We’ve known that the antipsychotic group of drugs can cause cardiac changes.
08:17
Speaker A
We’ve known this for over 50 years. Psychiatrist David Healy has written several books and papers on psychopharmacology.
08:30
Speaker A
It seemed to be a reasonably small problem. It seemed to be that the regulators had taken care of the drugs that were the major problem and made sure that they weren’t on the market.
08:43
Speaker A
What I didn’t realize and what most people didn't realize is that almost all of these drugs can cause some degree of cardiac change.
08:54
Speaker A
It may not be so bad that the company has to warn that their drug can kill you, it may not be so bad that the regulators pull the drug off the market, but actually if you end up on a few of these drugs
09:07
Speaker A
and they all cause a bit of a problem, you can end up with a very large problem.
09:13
Speaker A
You can end up just dropping dead. In 2009, I gained access to leaked internal documents about Zyprexa, one of the medicines Renate had been treated with.
09:34
Speaker A
At the time, I knew very little about the pharmaceutical industry, and it took me years to sift through the papers and make sense of what I was reading.
09:44
Speaker A
But one thing was clear: people struggling with mental illness were valued only in terms of how much income they could generate as lifelong customers.
09:56
Speaker A
Lilly is the company that produces Zyprexa. They are also the makers of Prozac. It’s the hottest psychiatric drug in history.
10:07
Speaker A
Prozac. The wonder drug that works wonders. ...Americans using Prozac right now... The holiday season in New York City when the drug dealers are selling more Prozac than crack.
10:19
Speaker A
Prozac completely changed the practice of psychiatry by allowing depression to be diagnosed and treated by general practitioners instead of psychiatrists or psychologists.
10:31
Speaker A
Prozac quickly became the biggest selling drug in the history of the pharmaceutical industry. But in 2001, Lilly lost their patent exclusivity for Prozac.
10:44
Speaker A
Prozac was your number one selling multi-billion dollar blockbuster as of that time, right?
10:52
Speaker A
It was.
11:07
Speaker A
This is their annual report when they lost it. "So what are we going to do now?"
11:17
Speaker A
"We're gonna use as our front line... we'll start replacing Prozac's business
11:35
Speaker A
with Zyprexa's business and make it into a billion dollar blockbuster."
11:56
Speaker A
Lilly introduced an aggressive sales program called Viva Zyprexa, with its own theme song. A reworking of Elvis Presley's Viva Las Vegas.
12:05
Speaker A
“Whole new purpose gonna set my soul / Set my soul on fire /
12:10
Speaker A
Got a brand named Zyprexa with a whole new chance to get those stakes up higher /
12:25
Speaker A
Thousands of patients waitin’ out there / the way they’re livin’ just ain’t fair /
12:32
Speaker A
but you can bet they can get some help from primary care / Viva Zyprexa!” New York Times journalist Alex Berenson has covered the pharmaceutical industry extensively.
12:45
Speaker A
He was the first journalist to access the leaked documents about Zyprexa. Most products you can’t sell for $5 if they cost 5 cents to make.
12:58
Speaker A
The reason you can with drugs is because drugs are given monopolies for a period of years.
13:13
Speaker A
The day that a new drug is approved is a great day for a company, but it also starts the clock to that expiration and everyone is aware of that, everyone is aware. We want to maximize our profits in that
13:21
Speaker A
13, 15, 17 year window for as long to get as much as we can, build the market as much as we can.
13:35
Speaker A
I don’t know if you remember this... Oh, yes. You know, this is Zyprexa in primary care; primary care physicians, not psychiatrists, certainly not mental hospitals.
13:42
Speaker A
We’re gonna go to your GP. Lilly used the same strategy as with Prozac. They marketed Zyprexa aggressively to primary care physicians.
13:52
Speaker A
The difference from Prozac was that Zyprexa was only approved to treat schizophrenia and a rare type of bipolar disorder, so Lilly had to convince doctors and consumers that they were not depressed anymore but that they were bipolar.
13:58
Speaker A
Your doctor probably never sees you when you feel like this.
14:04
Speaker A
This is usually who your doctor sees.
14:24
Speaker A
That deeply depressed you who barely dragged yourself in for treatment.
14:32
Speaker A
That’s why so many people with bipolar disorder are being treated for depression
14:38
Speaker A
and not getting any better because depression is only half the story.
14:47
Speaker A
That fast talking… Amazingly, Zyprexa became an even greater source of income for Lilly than Prozac had been.
15:00
Speaker A
But then it turned out that Lilly had skeletons in their closet. Eli Lilly pleading guilty to criminal conduct after skating under the radar for years.
15:22
Speaker A
There’s been rapid weight gain with the drug and elevated glucose which can put folks at high risk of developing diabetes.
15:40
Speaker A
So what is Zyprexa used for? Lilly was hit with over $1.6 billion in fines.
15:48
Speaker A
The reason? They knowingly hid dangerous side effects of Zyprexa and had engaged in illegal marketing practices called off-label marketing: marketing medicines for conditions it has not been approved for.
15:59
Speaker A
Thank you for calling Eli Lilly and Company.
16:10
Speaker A
The person you are trying to reach is not ac
16:15
Speaker A
No, yeah. That’s what he didn’t. He only knew it when I told him. So what I'm sort of trying to get in this film is: I want to find those people who made these strategies in the companies who knew that this was going to happen.
16:41
Speaker A
Corporate CEOs, marketing managers, people who either knew or should have known or did not know because inadequate safeguards were in place should be prosecuted civilly and criminally for the death and mayhem and plundering of the public treasury.
17:03
Speaker A
And until individuals are held accountable I believe the drug companies will continue to stretch every boundary and every rule that they can.
17:21
Speaker A
We are here today to announce that Johnson & Johnson and 3 of its subsidiaries have agreed to pay more than $2.2 billion to resolve criminal as well as civil claims that they marketed prescription drugs for uses that were never approved as safe and effective.
17:39
Speaker A
Allegations of conduct that recklessly put at risk the health of some of the most vulnerable members of our society, including young children, the elderly, and the disabled.
17:56
Speaker A
The biggest fines in the history of the US Justice Department have been levied against pharmaceutical companies, but the people behind these crimes are still walking free.
18:10
Speaker A
They're senior executives with pharmaceutical giant Glaxo SmithKline at a pep rally in Las Vegas for their sales team.
18:17
Speaker A
Who wants to be a millionaire? The goal to rev up sales is part of what prosecutors say was a culture of greed.
18:25
Speaker A
You do the math. There are people in this room who are going to make an ungodly sum of money.
18:32
Speaker A
The company apparently spared no expense to entice… It’s hard to say from the company’s point of view that these fines ultimately are not just the cost of doing business, because if you’re personally not at risk then you can do the math.
18:51
Speaker A
You say, well we made $40 billion selling Zyprexa over the last 15 years and the profit on that was $20 billion, and we had to pay a couple billion dollars in fines.
19:04
Speaker A
That worked out for our shareholders and that worked out for our executives. That worked out pretty well.
19:10
Speaker A
It was not only Eli Lilly, it was not only Merck, it was not only Johnson & Johnson, it was not only Pfizer, it was not only Warner Lambert, it was not only Glaxo, it was all of them.
19:21
Speaker A
You know I’d always read this stuff and I’d say oh these guys are the worst.
19:28
Speaker A
And then something else would come up: oh no! These guys are the worst! No, actually we thought Merck was the best and they’re the worst.
19:37
Speaker A
It was like, actually they’re all the same. They all run the same playbook, they all do the same stuff, they all have contempt for the doctors, they all have contempt for the science, they all just wanna sell as much as they can.
19:56
Speaker A
Did the people in the Pharma companies ever consider the human cost of these crimes?
20:07
Speaker A
I contact several insiders and nobody wants to talk. But one woman who was involved in crafting the Viva Zyprexa campaign agrees to meet with me.
20:21
Speaker A
But she backs out at the last minute. <i>I regret that I agreed to do this because <i>I had some reservations initially and I should have just stuck with my gut.
20:41
Speaker A
<i>Then you probably know that Lilly has spent some time in court <i>and you probably know that I've spent some time in court as a result of that.
20:47
Speaker A
No actually, I knew that Lilly had problems I didn't know that you personally had been in court.
20:53
Speaker A
<i>Well, I had <i>because I was stupid enough to answer my door when two federal agents came by.
21:00
Speaker A
<i>And with regards to Lilly, we did nothing wrong, we were pretty much just following orders.
21:10
Speaker A
<i>I mean there's a reason why everybody knows the names <i>Coca-Cola, Marlboro, and Prozac all around the world.
21:16
Speaker A
<i>There's a reason. It's no accident. It seems that our calls are starting to ruffle feathers.
21:31
Speaker A
We receive emails and messages from anonymous senders. Who they are, I don’t know, but the message is clear.
22:01
Speaker A
<i>Anniken! Anniken, come! When someone you love suffers from serious mental illness you take on that suffering as well.
22:20
Speaker A
It’s as if your entire family and everyone close to you is falling ill as well.
22:33
Speaker A
I remember the moment I realized that there was something seriously wrong with Renate. I was 10 years old, she was 20.
22:51
Speaker A
She began covering her hair with a scarf. I asked her why she was doing that and with fixed eyes that wouldn’t make contact with mine she said: “God ordered me to do it. If you don't do what God commands you’ll be punished.”
23:23
Speaker A
I couldn't understand what happened to her because suddenly she was a stranger to me.
23:30
Speaker A
Completely different from my Dadya. After that, Renate was in and out of psychiatric care over the next 14 years.
23:47
Speaker A
Several times she was committed against her will. Having witnessed my sister in a psychotic state many times I understand the need for medicine in such serious conditions.
24:13
Speaker A
I wanted to find research that proved the positive effects of antipsychotics so I contacted the largest research institution in the world on mental health.
24:22
Speaker A
<i>Hi, this is National Institute of Mental Health. <i>Yes. <i>Right yeah... <i>Yeah, I wish I...well, I'm sure there are...but I'm...
24:42
Speaker A
<i>I don't have anyone...I <i>will be able...I should be able to refer you to somebody who's got, <i>positive studies, um....so I'll send you that, ok?
24:59
Speaker A
They couldn't provide me with a positive study. Instead, they sent me this one: claiming that antipsychotics are neither safe nor effective for adults over 40.
25:14
Speaker A
I found this very strange because antipsychotics are used by millions every day all over the world.
25:25
Speaker A
So I try to understand exactly what these medicines do and how they work, only to discover that the theory behind them lacks proven scientific evidence.
25:39
Speaker A
Psychiatrists routinely tell patients that they have a chemical imbalance. So they have an error in their brain and now we will give a drug that fixes this error.
25:51
Speaker A
And this is totally wrong. 80% of Danish patients believe in this myth and this is because the psychiatrists have told them this lie and for example in depression the popular saying among psychiatrists is that you lack serotonin in your brain and this is why you are depressed
26:15
Speaker A
so now we will give you a drug that increases serotonin. But it has never been shown that depressed people have less serotonin in their brain than normal people.
26:33
Speaker A
The theory that has enabled the massive use of antipsychotics and antidepressants is the chemical imbalance theory.
26:42
Speaker A
It claims that mental illness is caused by an imbalance of chemicals in the brain and the medicines correct these imbalances and you get well.
26:53
Speaker A
We really don’t understand the pharmacology of these drugs very well and therefore we have no idea what they are going to be doing when used in combination.
27:02
Speaker A
We have no idea what they’re doing, you know, when we’re using one of them.
27:05
Speaker A
Especially, using one of them for a long time. People have been trying to locate what they assume to be the biological origins of mental illness for many decades now.
27:20
Speaker A
The research is always reported as making progress, and it will be just around the corner, we will find it soon, but we haven’t quite found it yet.
27:30
Speaker A
In the 90s, medical journals were filled with studies and ads about chemical imbalances and new revolutionary medicines.
27:38
Speaker A
But that tale is no longer being told in the medical journals. So I took a closer look at the ways in which medical literature is manipulated.
27:50
Speaker A
The pharmaceutical companies themselves control all clinical trials of a new medicine. Around 50% of these trials are withheld by the company.
28:01
Speaker A
So clinical trials with negative results will not be seen by researchers, doctors, or us.
28:07
Speaker A
And medical journals often publish only those studies with positive outcomes. Articles in peer-reviewed journals like The BMJ, The Lancet, JAMA, The New England Journal of Medicine - these are very powerful for affecting physicians' beliefs about diseases, their beliefs about therapeutics, and their practice.
28:29
Speaker A
They are probably the most important marketing tool that pharmaceutical companies have. So it’s quite common for pharmaceuticals to either ghostwrite or ghost manage articles that appear in the medical literature.
28:50
Speaker A
Marketing messages are given to the writer and then an academic physician or researcher is asked to author the article and then there are people who specialize in writing the abstract for an article.
29:06
Speaker A
Abstracts are not peer-reviewed and often abstracts do not reflect the actual data underlying the paper.
29:13
Speaker A
So busy physicians will only read the abstract. And the most important part of the abstract? The conclusion.
29:20
Speaker A
So if the last line of the abstract says: “we think that the promise of this treatment will emerge in a later trial even though it was a negative study,” the physician is left with a positive impression of the drug.
29:39
Speaker A
The pharmaceutical industry indirectly funds several of these journals through advertising. This brings us to the most important person in the selling of prescription medicines: your doctor.
29:51
Speaker A
Because it's through the doctor’s prescriptions that the companies make money. Do you think doctors are aware of how much they are actually being manipulated?
29:58
Speaker A
No, most doctors are not aware of how they are being manipulated, and one of the reasons is that it's very subtle, it's very pervasive.
30:08
Speaker A
Even a physician who never goes to a drug company dinner and doesn't see drug reps and doesn't accept samples, they are still being manipulated because the information in medical journals is being manipulated.
30:21
Speaker A
The information at national meetings is being manipulated. The information that academic physicians are giving to community doctors is being manipulated.
30:31
Speaker A
So even a very honest, well-meaning, ethical physician is still not getting the information that they need to practice the best medicine.
30:43
Speaker A
And industry will always promote the benefits of drugs and minimize the harms of drugs.
31:00
Speaker A
Pharma companies employ thousands of sales reps who pay regular visits to your doctor's office to market their products.
31:08
Speaker A
The sales reps have one goal: to make your doctor prescribe the drug they are marketing.
31:15
Speaker A
They arrive with free lunches, invite doctors to dinners and conferences, and distribute promotional materials.
31:22
Speaker A
No medical background is required to be a sales rep, but they are trained extensively in selling techniques.
31:34
Speaker A
While marketing Zyprexa, Lilly created patient profiles to help sales reps teach the doctors to discover the Zyprexa patient.
31:47
Speaker A
These profiles could be each and every one of us during a challenging period of our lives.
32:06
Speaker A
What I remember most about Renate is her smile. When Renate was 25 she met the love of her life.
33:02
Speaker A
A few years later they became parents to a beautiful girl. The whole family was overcome with joy.
33:22
Speaker A
But Renate was too ill to keep custody of her little girl. Her smiles became rarer and she slipped deeper into herself, to a place where I couldn't reach her.
33:55
Speaker A
Welcome to the European Parliament in Brussels. The democratic center of the... In Europe we have the tendency to think everything is worse in America, but this is a global industry and its practices affects us all.
34:12
Speaker A
Our authorities both in the US and Europe have approved the antipsychotics without discovering their real dangers.
34:21
Speaker A
So who approves our medicines? I always believed that it was the Norwegian Medicines Agency that approved medicines in Norway, but most medicines in Norway are approved through the EMA: European Medicines Agency.
34:42
Speaker A
Norway has no formal decision-making authority within the EMA, which is an agency of the EU.
34:51
Speaker A
The regulators don't do any independent testing of medicines prior to approval. All research and testing is designed and conducted exclusively by the company seeking approval.
35:04
Speaker A
The EMA only reviews the data the pharmaceutical company presents to them. Based on this, they make simple analysis: do the benefits outweigh the risks?
35:19
Speaker A
The Zyprexa approval was based on 4 clinical trials of 3000 people over a mere 6 weeks.
35:26
Speaker A
Trials lasting little over 1 month for a drug that most people will take for years.
35:35
Speaker A
Patients given Zyprexa showed slight symptom improvement over those given placebo or other antipsychotics. There were side effects but they were deemed minor, so the benefits outweighed the risks.
35:51
Speaker A
Many of Zyprexa's dangerous side effects such as diabetes or sudden death didn't show themselves during the trials.
36:01
Speaker A
The real dangers only became clear after Zyprexa was introduced into the population at large.
36:09
Speaker A
This is how it works with nearly all medicines on the market. It is only after they have been approved that the real side effects are known.
36:20
Speaker A
So we, the consumers, are unknowingly the guinea pigs for new medications. It took me two years to get an interview with the EMA, but I did get one with their senior medical officer.
36:45
Speaker A
Where should we place the responsibility when something like this happens? And I mean here are thousands and thousands of people who have died.
36:52
Speaker A
Some hardship, some damage to patients, as regrettable as it may be, as it is, is unavoidable.
37:00
Speaker A
Now having said that, there may be situations where someone doesn’t live up to their responsibility.
37:07
Speaker A
Whether it is the doctor or maybe even the patients themselves because they take the wrong dose or they take it irregularly and undisciplined.
37:14
Speaker A
Or whether it is the pharmaceutical company or the regulator because they don't pick up signals.
37:19
Speaker A
That may happen. But it is very difficult to say there is in general this responsibility that wasn’t met.
37:27
Speaker A
We regulate medicines; we do not regulate the practice of medicine. It is a judgment call that has to be taken by regulators in the best interest of patients.
37:39
Speaker A
But you don’t know the risks - in this case. - You never know all the risks.
37:43
Speaker A
Well then how can you say there’s risk benefit balance then? - It doesn’t make sense if you don’t know... - The known benefits and the known risks.
37:51
Speaker A
We have to be honest. And I think we all have to accept as a society, whenever you bring in programs there will always be unknowns.
38:01
Speaker A
So the EMA makes a judgment call based on benefits versus risks. How did they measure the value of the lives that would be lost?
38:18
Speaker A
The pharmaceutical lobby in Brussels is powerful. They declared to have spent over €40 million lobbying in 2015.
38:34
Speaker A
The pharma lobby enjoys easy access to decision-makers and offers expert advice on EU laws and the drafting of regulations.
38:47
Speaker A
And after years of trying to get an interview with someone from the industry, I finally succeed with the head of Europe's pharmaceutical lobby association, EFPIA.
38:59
Speaker A
We still are not transparent enough about how we go about things. The fact that medicines are developed in partnership.
39:06
Speaker A
When you see on TV, you see usually a man in a white coat talking about how this was developed.
39:12
Speaker A
The fact that there’s a company behind and the government is involved as well, this is not known.
39:18
Speaker A
You think that this is some researcher doing this. But a researcher at Oslo university or wherever doesn’t have €100 million lying around for a clinical trial.
39:28
Speaker A
No. So all of this is coming from the industry. Yeah, so let’s go back to the system of getting drugs approved.
39:35
Speaker A
If we look, for example, at the antipsychotics, how could it have been approved in the first place and not discovered that prolonged QTC was a side effect and that sudden death was a side effect?
39:45
Speaker A
Sometimes we simply don’t know. Sometimes we find out rare side effects once they’re out there in the market.
39:52
Speaker A
And the reason why is that we still do not know enough about diseases. We don’t know why if you give an antidepressant to someone, there is only a 50% chance it will work. Why is that?
40:04
Speaker A
Is that because we are stupid? No. We are not stupid. The regulators are not stupid.
40:08
Speaker A
The doctors are not stupid. It’s just that we don’t know enough about the science.
40:11
Speaker A
We don’t know enough about this disease. This is both the beauty and the frustration with science is that you have a study that concludes this and then you have a study that concludes this.
40:21
Speaker A
I mean if you take all the advice we get on nutrition are you a little bit lost as I am?
40:26
Speaker A
Salt, good or bad? I don’t know. Now, what I am happy about is we have these regulatory agencies that really control the products and what you can say about them.
40:45
Speaker A
87% of the EMA's budget is funded by the pharmaceutical industry. So the controllers are paid by the very industry it is meant to control.
41:04
Speaker A
The people who are supposed to control the public good to make sure the medicines are safe and they work, many of them worked for the pharmaceutical industry themselves beforehand.
41:15
Speaker A
Or when they leave their jobs will go directly into the pharmaceutical industry. This happens with the FDA in the United States, it happens with the EMA and this is scandalous.
41:25
Speaker A
So, unless we have independent controllers, the whole scientific methodology of whether our medicines are efficacious, whether they work or whether they’re safe, has been broken.
41:40
Speaker A
And we’re dealing with a broken system. I think Renate’s deepest sorrow was that she was unable to be a mother to her daughter.
42:09
Speaker A
On her daughter’s fourth birthday, my aunt and I went to visit her. The nameplate on the door had both Renate’s and her daughter's name.
42:23
Speaker A
A pair of children's shoes were in the hallway. Renate is happy to see us and she hasn’t forgotten that it’s her daughter’s birthday.
42:39
Speaker A
Happy birthday to you, happy birthday to you. Renate has bought a birthday cake. She sets the table for the three of us and her daughter.
43:00
Speaker A
She cuts the cake and puts the first piece on her absent daughter’s plate. Happy birthday dear… Happy birthday...
43:34
Speaker A
I'll never forget the image of the uneaten piece of cake still on the plate when we left.
43:57
Speaker A
It's impossible to determine the accurate number of deaths caused by antipsychotics. Scientists estimate at least 200,000, but I keep finding reports on deaths.
44:08
Speaker A
This 16 year-old died of cardiac arrest... This 15 year-old male died approximately… This 7 year-old experienced a...
44:17
Speaker A
The FDA, The Food and Drug Administration, is the regulator in the US. Eleventh floor.
44:33
Speaker A
Over a long period of time I was in contact with a former FDA drug reviewer.
44:39
Speaker A
He was reluctant to meet me and seemed nervous and insecure about exposing what he had experienced while working at the FDA.
44:47
Speaker A
He tried to blow the whistle to Congress, but his efforts were met with threats.
44:55
Speaker A
Do you feel that in your time as a drug reviewer there were things that you saw that actually could have saved lives?
45:03
Speaker A
Absolutely. Absolutely. I was at the FDA for 10 years and at one point I calculated that I caught a safety issue on average once every six weeks of some sort.
45:25
Speaker A
And I had a number of safety issues, major safety issues that had been repeatedly dismissed.
45:38
Speaker A
There's a lot of money involved, there's a lot of money involved. I saw a lot of things in my time at the FDA.
45:48
Speaker A
There's a lot of good people there. A lot of good people. You don't see the good people getting promoted.
45:56
Speaker A
They basically…a lot of them either leave or they decide just to keep their heads down.
46:04
Speaker A
And they may even write their reviews and say “I think this is an issue,” but then what happens is almost invariably issues just...
46:18
Speaker A
“well we’re management, we don't agree with you” and so long as you don't push it you're allowed to continue with your career.
46:34
Speaker A
Everything that I have seen is ultimately designed to get drugs to market quicker and to provide less safety oversight.
46:54
Speaker A
Thousands and thousands of people are dying and nothing is being done to stop it.
46:59
Speaker A
Yes. Nothing is being done to talk about it and there are people who knew from the very beginning that this would happen.
47:07
Speaker A
If I make that assumption do you think that I'm right? I think so. I think so.
47:39
Speaker A
It was during my interview with the head of the European Pharma lobby in Brussels that I came to understand how we are at the breaking point in history because the pharmaceutical industry has new plans for us and our future.
47:54
Speaker A
So we are moving big time to something we call targeted medicine. So all these projects now which are in diseases like schizophrenia and depression are looking different.
48:04
Speaker A
You’re not selecting patients based on signs and symptoms. You’re actually doing a genetic test, or you test a blood sample or something. You will find out the reason.
48:13
Speaker A
The reason why they are schizophrenics from a blood test or a genetic test? Yes.
48:17
Speaker A
Okay but earlier you told me we do not know enough about the brain we don't know how it works and we do not know what causes depression or schizophrenia or anything.
48:25
Speaker A
The atypicals or the antidepressants were based on specific science that says we know what causes this disease and this molecule works on - the dopamine receptors…. - ...the knowledge of science at that time.
48:36
Speaker A
But now we’re starting to figure out what is the real reason. Ok, what is the real reason?
48:42
Speaker A
Well, that’s why we have these science projects, we don’t know yet. It could be a mutation. It could be...I can find the - scientific papers and send them to you… - I would love to see it.
48:51
Speaker A
All of these diseases are going to be caused by something. Either it’s a wiring problem, physical wiring problem, that maybe some neurons are not connecting enough.
49:01
Speaker A
What are you going to do about that? Maybe you have to go in and engineer it.
49:04
Speaker A
Nano-engineering. Really exciting. In the really long run, you can do gene therapy. Which means that you‘ll be able to pick this up in your children or when you grow up.
49:17
Speaker A
So that means if I had somebody in my family who had schizophrenia you could just take a gene test and you’ll say yeah you probably will get it too?
49:24
Speaker A
That’s the future. The science is extremely exciting. When lobotomy was first introduced it was heralded as a great advance in science.
49:42
Speaker A
But now lobotomy has been condemned. When we look back at the age of psychopharmacology, how will history judge us?
50:15
Speaker A
Your daughter has grown up. She’s 18 years old. You would be so proud of her if you could see her now.
50:25
Speaker A
She looks so much like you. The last time I saw you, Dadya, you were standing in the doorway after I came to visit you.
50:49
Speaker A
I can still feel the touch of your cheek on mine when you hugged me for the last time and your smile when you said “love you.” After walking a few steps away from the house, I suddenly turned around and looked back.
51:12
Speaker A
You were still there waving and smiling at me. How I wish I could freeze that moment, run back, and hug you just one more time.
51:27
Speaker A
Tell you how much I love you, one more time. Say goodbye, one more time.
51:39
Speaker A
This is my last goodbye.
Topics:antipsychoticspharmaceutical industrymental illnessZyprexaEli Lillyside effectspsychiatrydrug safetyoff-label marketingsudden death

Frequently Asked Questions

What was the main focus of the film 'CAUSE OF DEATH: UNKNOWN'?

The film investigates the mysterious death of the filmmaker's sister, exploring the role of antipsychotic medications and the pharmaceutical industry's influence on mental illness treatment.

Why were warnings about sudden death added to antipsychotic drugs after Renate's death?

Warnings were added two years after Renate's death due to evidence linking antipsychotics to cardiac changes and sudden death, which had been previously underrecognized and underreported.

What illegal practices did Eli Lilly engage in regarding Zyprexa?

Eli Lilly was fined over $1.6 billion for hiding dangerous side effects of Zyprexa and for illegal off-label marketing, promoting the drug for conditions it was not approved to treat.

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