Interview with Professor Dr. Peter C. GØTZSCHE, author of “Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare”, for Slovak internet radio station Slobodný vysielač on May 10th, 2016
Slovenská verzia Slobodný vysielač — Tuesday, May 10th, 2016 —
— Professor Dr. Peter C. GØTZSCHE (PCG), interviewed by Marián FILLO (MF)
Many thanks for English spelling and grammar corrections and improvements to
Claudia MILLWISCH and Helen KIMBALL-BROOKE.
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MF: Good afternoon, Peter! Welcome to our show!
PCG: Good afternoon! Thank you.
MF: Thank you very much for joining us. I think people can read what's in your book, so I won’t focus on its content but would like to ask some complementary questions and have prepared a list. You wrote about the placebo-controlled clinical trials conducted when testing the effectiveness of some drugs, that these tests are often not double-blind. They just look as if they are double-blinded but in fact they are not because the study group experiences some side effects from the drug, the active substance, and therefore they know they are taking the active drug and not the placebo. Is this correct?
PCG: Yes, that is very important, because drugs are being approved by drug agencies, if only two trials have shown some effect over placebo. But since these trials are not adequately blinded, we know that the effect is often exaggerated and for example, if you put something into a placebo, that also gives people side effects (this has been done in depression trials) then antidepressant drugs no longer have any effect. Generally, if you put something in a pill that gives people side effects, patients and doctors will think it works for depression, and if a pill doesn't give side effects, they think it doesn't work for depression. So I had come to the conclusion that antidepressant drugs likely don't work for depression. What we see is only the effect of inadequate blinding and this is true for many of our drugs. Also, drugs against dementia, drugs against urinary incontinence and lots of other things — these drugs likely have no effect, while they certainly have side effects and in some cases their side effects can be lethal for people. So we should use drugs much much less than we do today.
MF: I couldn't agree more but my question is: If we are testing effectiveness, we should use an active placebo which brings some side effects but no therapeutic effect. What about testing safety? In the safety tests, if we have an active placebo which provides the therapeutic effect and has no or almost no side effects, then this test would be unethical, because we already have a drug, which we know causes far fewer side effects than the tested substance. Do you see what I mean?
PCG: No, quite the opposite. These trials are not unethical at all. What is unethical is that we approve and bring to market so many harmful drugs with the false belief that they have an effect against a disease. So in many cases we are just introducing a lot of harm into the population, some of which is lethal. So it is not unethical at all. I mean we still do many placebo-controlled trials of antidepressant drugs, so why would it be unethical to put something into the placebo that gives people side effects? I'm not talking about lethal side effects, of course. I'm just talking about things that people can feel. They can feel that they are getting something. In this case, the comparison with the active drug would be much more reliable.
MF: I understand, but it is about testing effectiveness. What about testing safety? Because when testing safety, a trial could be unblinded when the individual experiences some therapeutic effect of the real drug. Then you know it is the real drug, not the placebo, and as such you may feel better and suppress or mentally suppress the side effects.
PCG: But if we tested drugs the way I propose, with active placebos, which are not really active but just contain some substance that gives people side effects… If we did that, a lot of drugs would never make it to market, so there would be no interest in studying the safety of drugs that never come on the market.
MF: Aha… OK, I get it.
PCG: And in those cases, where you actually do find an effect despite the placebo giving people some side effects, then you are right: how will we know exactly what the side effects are of the active drug? But in that case you could simply do traditional trials with inactive placebos after that in order to get more reliable data on the side effects.
MF: But such trials would not be double-blinded.
PCG: No, they wouldn't be double-blinded, but some side effects are so conspicuous, that there is no doubt they are real. For example, if people get violent nightmares on antidepressant drugs, if their sex life is destroyed, which occurs for half of those who take antidepressant pills, they get their sex lives damaged… I mean there are some effects that are pretty difficult to explain away.
MF: OK. When a drug is pulled from the market in one country, it often remains on the market in another. Shouldn't this somehow be synchronized all over the world, maybe via the World Health Organization or another institution so that when it is proven in one country that a drug is much more dangerous than useful, then it should be prohibited all over the world?
PCG: I agree completely with you. Drug research is international and drug regulation should also in a way be international; it should lead to approximately the same results in all countries. Unfortunately, there are some third world countries where there is a lot of corruption. We also know that there is corruption in Europe, of course, but it is worse in some third world countries, where you can actually bribe drug regulators to get dangerous drugs out on the market, drugs that are forbidden in Europe and America. We have seen many examples of that and it is deeply unethical, of course.
MF: Yes, for example, if I'm not mistaken, Thalidomide is still sold in several African countries while it has been outlawed in Europe and the USA for years. But it is still sold under another name — it's not Contergan anymore, I don't know what it is called now, — but the active substance is the same.
PCG: Yes, you are right. Babies are still being born, for example in South America, that are deformed and might not have arms, seriously deformed babies, because drug regulation is not good enough in these countries. Thalidomide is used for some rare skin diseases, even in the Western world, but this is under very close supervision so pregnant women wouldn't be treated. Sadly, there is much less drug regulation and safety in third world countries. That's very tragic.
MF: OK. You have mentioned several times in your books that Paracetamol (Acetaminophen) is much better for many uses than the much more expensive drugs, but maybe you know this: Paracetamol is the leading reason for visits to toxicology centers in the UK, for example. It is maybe the most overused drug in the world and quite harmful for people who use it too often or too much. So wouldn't it be better to have Paracetamol as a prescription drug instead of over-the-counter?
PCG: Well, the main problem with Paracetamol is when people take too many pills because they want to commit suicide and these suicides are very tragic because typically it can be a teenage girl, who never thought that she might die from this; it's more a desperate cry for help. They just take some pills their mother or father has at home and then they die from liver failure. This is very very tragic. And maybe you are right that Paracetamol should be available only on prescription, but you also need to look at the number of people who die from Paracetamol. Virtually no one dies from Paracetamol when they take the drug as indicated and not as a suicide attempt. So Paracetamol is quite safe if taken in the recommended doses, whereas arthritis painkillers, like Ibuprofen or Diclophenac, are not safe at all. We have known for many years that many people die from bleeding stomach ulcers when they are treated with these, and we now know that many of these pills double the risk of getting a heart attack. So many people are killed that way. The total number of people killed by these arthritis drugs is just enormous. It's one of the major killers we have.
MF: So these drugs are not just painkillers, they are killers as such.
PCG: Yes, they kill patients in large numbers.
MF: They kill patients along with the pain.
PCG: Yes, but the tragedy with these drugs is that many of the people who died from them never needed the drug in the first place, because they are used for everything, like migraine, back pain, knee pain or whatever you can imagine… where you can use other much safer drugs, like Paracetamol and other drugs. So this is reflecting a drug industry that is in many ways criminal. The industry has cheated on many of the clinical trials. For example Merck & Co. omitted cases of heart attack in its trials and so on, and deaths then disappear from published trial reports, so people don't know how dangerous these drugs really are.
MF: OK. I just wonder whether it is possible to have a synthetic (synthesized by human) molecule, not found anywhere in Nature, a molecule which would be safe and effective, because Nature gives us many remedies we can use for example instead of these arthritis drugs and which are much safer. Do you agree?
PCG: No, I don't agree actually. You should not have any romantic ideas about Nature being safe. Nature has never been safe and a lot of the things that you can extract from herbs are actually highly toxic and kill people, so one should not be naïve here. And many of these herbs, which are not poisonous and not dangerous, don't have any therapeutic effect either, so why should you take them? And some of the drugs we have, come from Nature, and some started with a natural substance which was then changed slightly in the laboratory to become a new substance with very much the same effects as the natural substance. So there are no guarantees.
MF: Yes, but you can't patent something which is found in Nature, so pharmaceutical companies change it slightly; it has the same effect, but they can then sell if for, for example, a 100 times higher price.
Professor Dr. Peter C. Gøtzsche PCG: Yes, but now you are into something else: that it is fundamentally unethical to patent substances that are developed in order to help sick people. This is unethical. If some item of merchandise is patented and it is sold for a high price, then you can decide:
“Well, I don't need to buy this. It's just too expensive. I can do without that.”
But if you have a life-threatening disease, you cannot just say:
“No, I won't buy this, because it's too expensive.”
because you might die if you can't buy it. So it's very unethical that we have created a system where we patent drugs. Patents should go out completely, because they are also used to extort us. Nowadays some new drugs are sold at exorbitant prices our societies cannot pay. So it's a kind of extortion that we can only get rid of if we get rid of our patent laws and also if we make drug development a public enterprise and not a capitalistic one.
MF: OK, but we had that. During the communist regime all drug companies in (Czecho)Slovakia were state-owned, but during the 40 years of communist reign the consumption of drugs rose dramatically — even when the drug companies were owned by the state. So I don't think it is enough to have them in the public domain…
PCG: Oh, if development of drugs became a public enterprise, I tell you that we would see a quite different world from what we see today. If the public sector became involved in drug development, we would focus much more on the harm caused by drugs than we do today, while the drug industry actually very often hides the harm caused by their drugs. We would be interested in finding out what the harm is, equally much as we would be interested in finding out what the benefits are. And in such a scenario we would use far fewer drugs than we do today. So we would actually have a healthier population that would live longer if the development of drugs became a public enterprise.
MF: OK, I agree with you, that it would be much better than it is now, but we have already been through such an experience and it was, well, maybe better, but certainly not best, because many people were overusing drugs: maybe they didn't want to go to work that day, so they went to a doctor and it is almost impossible to leave a doctor's office without a prescription, so the doctor usually prescribed something which wasn't necessary. This was also during the regime which produced the pharmaceuticals in publicly-owned companies.
PCG: Well, you know, just because you get a prescription from your doctor doesn't mean that you should go to the pharmacy and get the pills and take the pills. What I always suggest, when I give public lectures, is that people should look on the internet to find the package insert for the drug that their doctor prescribed for them. And if they do that, they will see that this drug has a lot of side effects, some of which are often quite serious and may even be lethal. So if patients really looked up what the drugs do to them, I'm sure that many people would not take drugs. I worked in the drug industry when I was a biologist. That was before I became a medical doctor. And I did research on Naproxen, an arthritis drug. One day I looked at the package insert and when I saw in how many different ways that drug might kill me, I promised myself, that for the rest of my life I would never take such a drug. So, you see, it's possible to be more proactive as a patient. And it's very strange, because when you ask people what their confidence is in the drug industry, they always put it at the bottom, together with their confidence in the tobacco industry and automobile repair shops. They don't have any confidence in the drug industry at all. They don't trust the drug industry but they trust their doctor. So when the doctor writes a prescription, they trust the prescription and that drug, but they shouldn't, because they should ask themselves:
“Where did my doctor get his/her knowledge about drugs?”
From the industry that I don't trust! So therefore I shouldn't trust the prescription either. I should go and look for myself and find out all the harm caused by this drug. And I should also ask my doctor:
“What happens if I don't take the drug?”
I may be fine, which in many cases will be the case; if after a few days or a week you will definitely be fine even without treatment, then why should you be treated? I mean why should you treat a pain that is temporary? We all get back pain now and then. I couldn't dream of taking a painkiller when I have back pain or pain somewhere else. Why should I do this?
MF: OK. So should we apply this also to vaccines? Because many vaccines are against such benign diseases that their side effects are often much more harmful than the disease they should prevent? Like chickenpox, for example.
PCG: That is a strange comment. I am not aware that the vaccine against chickenpox is worse than the disease.
MF: Then you should read the package insert.
PCG: Well, no, you cannot weigh the benefits against the harm by reading the package insert. You need to study the science, and childhood vaccinations are usually very beneficial. For example, take vaccinations against measles or rubella… If you are pregnant and get a rubella infection, you might give birth to a deformed child, a seriously-harmed child with brain damage and so on. So there are many childhood vaccinations that are very very beneficial. And, well, we can say that the harm they might cause is small compared to the benefits. So I would not be in any doubt that my children should have their childhood vaccinations, which in fact they have had.
MF: OK, but there are some diseases like influenza for adults, who are otherwise not ill, and maybe HPV — we still don't know whether it prevents cancer or not because for the licensing of this vaccine they used a surrogate endpoint (cervical intraepithelial neoplasia = CIN) and not the cancer itself. CIN could but also may not develop to cancer… You have written not a word about vaccines in your book. I am just wondering whether these companies, which behave in a quite immoral fashion, as you described, and also develop, research and market vaccines, whether they are also that corrupt when we speak about vaccines, or are they 100% honest with vaccines?
PCG: No, you cannot assume that everything is OK because the drug industry is more criminal than any other industry I have encountered. So you should be skeptical and watch everything that comes from a criminal industry. Now you mentioned influenza vaccines. One of my good friends and colleagues has done reviews of the influenza vaccines for the organization to which I belong — the Cochrane Collaboration, and I am one of many people who have decided that I will not get a flu shot because I considered that my likelihood of benefiting from a flu shot is so small and, on the other hand, I might be one of the unlucky ones that get side effects from the vaccine, so why should I do it? And I am definitely not the only one. I have worked in infectious diseases here in Copenhagen and some other people who are specialists in infectious diseases have also declared publicly on Danish television that they would not take influenza vaccinations, although they are 60 or 70 years old, an age at which these vaccines are often recommended. So there is a lot of individual choice here but you need to know about the benefits and risks before you can make your own decision, and few people have that knowledge. And then you mentioned the HPV vaccines. We are actually involved in that right now, not in terms of research but many people have contacted us because they are scared of the vaccine, because it is suspected that in very rare cases they might give rise to what we call autoimmune diseases, in which the body starts reacting against itself, because the vaccine proteins look like the proteins in your own body, so when you react to the vaccine, you also start reacting to your own proteins.
MF: So this is cross-reactivity.
PCG: Yes. I believe more research is needed before we really know what the HPV vaccines are doing to people and why there is this suspicion that very rarely some people might get severely damaged by the vaccines. We don't know yet, whether this is correct or not, and we need more research in this area. There is actually research forthcoming, that I know about, into the possibility that in rare cases these vaccines can cause autoimmune reactions. And then you talked about whether the companies have cheated also with these vaccines and I must actually say that you are correct, because only one of the trials used an inactive vaccine. It may seem as if I am contradicting what I said before but I'm not really contradicting myself. All the other trials used a placebo that contained the adjuvant which was used in the vaccine and which also contained aluminum, a highly toxic chemical. It's a neurotoxic chemical. It is in small concentrations but the companies have lumped together the placebo group containing adjuvants with the placebo group that was a true placebo group and that was only one trial. So when you put something in the placebo that might — in the worst case scenario — cause the same neurological damage that perhaps the vaccine is also causing, then it gets difficult to see that the vaccine can cause this damage, when the placebo might also cause it. So we have a problem here that we need to look into in greater detail.
MF: Well, it may be OK to test the effectiveness of the vaccine with an active placebo which contains an adjuvant, but not when testing safety.
PCG: No, you are absolutely right.
MF: And there is another point: most vaccine studies use another vaccine as the placebo, but it really is not a placebo at all. When testing meningitis vaccine, they used hepatitis A vaccine as a placebo. And then they say in the conclusions of the study that this vaccine was as safe as the placebo, which wasn't a placebo at all.
PCG: Yes, of course. The studies like that are problematic. You cannot conclude like that, because the two vaccines might produce the same side effects. So that has really gone too far.
MF: And there is another problem here: most vaccines aren't tested against completely unvaccinated people or aren't tested in the context of the whole immunization schedule, they are tested just as single vaccines, and we don't know what the interactions are between the vaccines in the schedule. Every several years we add another vaccine to the schedule but it is tested as a single vaccine and not within the framework of the whole schedule.
PCG: Yes, this is one of the problems we have with vaccines and with drugs in general: that we test one drug and one vaccine at a time. And what happens if you administer several vaccines at the same time? And what happens if you give several drugs at the same time? You increase the risk of serious damage because vaccines and drugs can interact with each other. So these are things we would like to know more about. You are absolutely right about that. And vaccines are interesting in many ways. For example: Danish researchers found out that vaccines we consider very safe here in Denmark, can actually kill people when used in Africa.
MF: You mean the work of Peter Aaby?
PCG: Oh, you know about it?
MF: Yes, of course.
PCG: Yes, that's correct: Peter Aaby's studies.
MF: These were quite interesting because they found out that some vaccines increase mortality while others decrease it.
PCG: Yes, yes, yes. So, we should always remember to be humble. Just when we think we know all we need to know, then a new crucial research study may come up, for example Peter Aaby's research from Africa, and then we realize: Oh it wasn't as simple as we thought it was. Basically, I would like to stress that people should use drugs far less than they do today. This is so important for me to say this. Also many people who are being treated for high cholesterol, high blood pressure, high blood sugar, they should try from time to time to lower their dose and perhaps even stop taking the drug and then see whether it's not all right, because even though you might have had high blood pressure at one point, two years later you might not have that blood pressure any longer and you could perhaps do without your anti-hypertensive drugs. Also if you lose some weight, that might cause you to no longer need these drugs, because it's beneficial to lose weight. So people should focus much more on what they are eating and try to develop a healthy lifestyle and follow a healthy diet. There are so many overweight people and we put a lot of drugs in these people when the main thing we should do is arrange courses for them where they learn over a week or two weeks how to cook and eat differently from what they eat at home. Maybe that is a solution. There are some very promising results. It's very difficult to make people change their diet but this is really what we should focus on, not these drugs.
MF: Maybe it's because of a sort of magical thinking — we think we have a magic pill and it will solve all of our problems without us doing anything against our nature, anything perceived as quite difficult.
PCG: Yes, but this blind belief in a magic pill is very harmful to people. I have estimated in my book that drugs are the third major cause of death after heart disease and cancer. And as I said, many of these people who died, didn't even need the drugs that killed them. So we could do far far better than we do today and one of my suggestions is that we should forbid all marketing of drugs. No more ads in doctors' journals, no more visits by sales people to doctors' offices, no more support from drug companies to patient organizations, to doctors and doctors' organizations and so on. We have outlawed the marketing of tobacco because the marketing of tobacco is very harmful but tobacco only kills about half as many as drugs do. We should also outlaw the marketing of drugs because we doctors will logically and automatically use all drugs that are good. We don't need any marketing for that. The science should speak for itself.
MF: Here‘s an analogy: It's like when I bring my car to a car repair shop. Let’s say the car represents my body. So I tell the mechanic (or the doctor):
“Do everything necessary and I will go work on my phone in the meantime.“
Then I go away later not caring what the mechanic (doctor) did. It is like that with doctors but what is necessary is that we take back the responsibility for our health from the doctors who should be much more like advisors than anything else.
PCG: You are right. I agree so much with you. We should see doctors as advisors, as consultants. We should not see doctors the way most people see them today, namely as people who somehow have taken over all responsibility for their patients’ lives. You know, it's so typical to hear this remark:
“But my doctor says… so, you know, I must do it, because my doctor says…”
But your doctor is not God. I mean, he's just a person, and your doctor may be wrong. People should take much more responsibility for their own lives. And I have had experience with that in my own family where a family member took a drug that was definitely harmful for her and she didn't even need the drug, so I tried to tell her and she replied
“Yes, but my doctor said so, so I will do what my doctor said.”
And then I told her:
“But your doctor doesn't know as much about this as I do. I have defended a thesis on this group of drugs. I know much more about this kind of drug than most people in the world and now you rely more on your doctor than you rely on me.”
This tells us how much authority doctors still have.
MF: Yes, they are like priests maybe 200 years ago: whatever a priest said should be obeyed as the word of God. But doctors are in fact not priests. Having said that, many of them still behave as if they were priests.
PCG: As if, you say, they were what?
MF: Many doctors behave as if they were priests, so it's a religious attitude towards medicine.
PCG: Yes, the most important thing for a doctor is, perhaps, to be humble.
MF: To listen to their patients.
PCG: If you do well and your patients like you and perhaps some patients even admire you, then the risk is that you may think too highly of yourself and start thinking that you know everything and you are infallible and things like that. Then you might become a dangerous doctor.
MF: This is true! So back to clinical trials, what about length of the studies? Take, for example, Infanrix Hexa, a vaccine which is certainly used also in Denmark: it is stated in a document about safety studies, but not in the package insert (so it's in another document), that its safety was clinically tested on the day of administration and over the following three days but no more. Is it OK for vaccine safety to be tested clinically over just 4 days?
PCG: Which vaccine are you talking about?
MF: Infanrix Hexa, the vaccine against diphtheria, tetanus, pertussis, hepatitis B, Hemophilus influenzae and polio — the six-valent vaccine.
PCG: Well, no, of course not. Everybody including the drug regulators knows that you need to follow these people up for a long time to see if they develop side effects, of course.
MF: And another point is that if we expect a drug or a vaccine to have an effect over a period of time, and in the case of vaccines it may be 5, 10 or 20 years, then we should also monitor side effects for the same time, because a side effect is also an effect. When we expect a drug to be effective for 20 years, then we should also study its safety for 20 years.
PCG: Oh, I never thought about that, actually. So let me try to think.
MF: For example when you have an antibiotic…
PCG: I understand, but, you know, vaccine damage doesn’t take 10 or 20 years to develop. At least I know of no example that would take so long. If you develop autoimmunity because of a vaccine, it doesn't take 10 years before…
MF: But maybe a year or two.
PCG: Well, it's certainly wise to follow people for a long time. And we are talking about years here; I agree with you. No matter whether you take drugs or vaccines, it's wise to follow people for a long time and yes, that's quite simple, but it's not always what happens. Drug regulators approve those drugs based on short-term experiments lasting only up to 4–6 weeks, even though people are expected to take the drugs for 10, 20 or 40 years. That's really not satisfactory. Particularly not considering the fact that the older you get, the more risky it becomes. Your risk of getting a heart attack increases, your risk of everything increases. So you also need to study drugs in old people.
MF: What about adverse effect under-reporting? Because, for example in Slovakia, general practitioners are obliged to report adverse effects of vaccines but it is explicitly stated in the law that they should report adverse effects, not events. So, usually they say:
“I don't think this is a side effect of the vaccine; I think it has no link to the vaccine, so I don't need to report it.”
— even if it is explicitly mentioned in the package insert as a possible adverse effect.
PCG: Well, reporting of adverse effects when a drug is on the market, is a very poor system of picking up even serious damage. We all know that this is a very very poor system. And one of the reasons why doctors don't report these things is that it takes time. Once, when I was in charge of an AIDS drug trial and started to report possible damage caused by the drug, I realized very quickly how much of my time this took, because then I had the company on my back and they kept on asking me all sorts of questions. So it took a long long long time just to report side effects for one person. When you're a busy clinician and you also try to do research and you're exposed to this kind of interrogation from the drug companies, then the risk is that you will stop reporting these effects, because you just don't have the time.
MF: I understand. One honest pediatrician told a mother I know that if they were to report all the adverse effects thoroughly, they would stay in their doctors' offices for an extra hour or two daily. As a result, they usually don't report anything.
PCG: Exactly. But in many countries now patients can report side effects directly to the authorities, so I always advise patients to do that. They are much more aware of side effects. Doctors often try to tell their patients that it's just in their minds, it's not a true side effect, so the patients should report it themselves. I'm sorry, but I will need to go to a meeting very soon now.
MF: OK. So thank you very much for your time and I hope your book will become a bestseller in Slovakia…
PCG: That would be nice.
MF: … despite being marked as “controversial” by an e-shop.
PCG: But this is a very bad thing. Who was it who said my book was controversial?
MF: I don't know.
PCG: People do also listen to the authorities… What nonsense was that? Where did that come from?
MF: I really don't know. I can ask.
PCG: Could you ask where this came from? Because if it is the company selling my book, I need to talk to them and stop that.
MF: No, no, no. It was an e-shop which has nothing to do with the publisher.
PCG: Ah, I see, OK. Then I can't do anything. Well, thank you so much. I need to go.
MF: OK. Thank you very much. Have a nice afternoon and best wishes from Slovakia!
PCG: Thank you so much for listening. Bye bye!
MF: Bye bye!
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You can listen to the original interview (without improvements of the used English language) here:
