“You can never trust randomized trials done by the pharmaceutical industry”

KARSTEN MONTAG, 30. Juni 2021, 0 Kommentare, PDF

_{Note: This interview ist also available in German.}

Professor Gøtzsche, born 1949, is a biologist, chemist and physician. He became professor of Clinical Research Design and Analysis at the University of Copenhagen in 2010. In 1993 he co-founded the Cochrane Collaboration, an international network of researchers that conducts systematic reviews and meta-analyses of interventions in healthcare in order to facilitate evidence-based decisions. Until 2018 he was the director of the Nordic Cochrane Centre, which he founded himself.

Throughout the years, he has pointed out

• that screening for breast cancer with mammography is harmful, as it leads to overdiagnosis and overtreatment and does not reduce total mortality,

• that the excessive use of psychiatric drugs causes vastly more harm than good, making these drugs likely the third leading cause of death after heart disease and cancer,

• and that the Cochrane review of vaccines against the human papillomavirus is biased and downplays the harms of the vaccination.

In the beginning of the COVID-19 pandemic, Professor Gøtzsche wrote that the drastic measures against the spreading of the virus was more a result of panic rather than being evidence-based science. In his book “Vaccines: Truth, Lies, and Controversy” he stated that the new coronavirus might not be worse than influenza viruses in terms of contagiousness and case fatality rate and explained that the reason why so many people died was likely that there was no pre-existing immunity against the virus, in contrast to influenza epidemics.

Multipolar: Professor Gøtzsche, in 2018 you were expelled from the Governing Board of the Cochrane Collaboration by a narrow majority of 6 to 5 because of an “ongoing, consistent pattern of disruptive and inappropriate behaviour”. In protest against this decision, four other elected members resigned from the board. In return, you accused Cochrane of bending to industry influence and overlooking important documentation of harms. How independent and trustworthy are Cochrane reviews nowadays?

Gøtzsche: Cochrane has 52 review groups in the world, three of them based in Denmark. Two of the groups in Denmark had tremendous problems with quality and performed badly. Shortly before I was expelled, I was assisting the Editor in Chief and deputy CEO of Cochrane, David Tovey, who had done audits in order to improve the poor quality of their reviews. But it didn’t work out. So, Cochrane decided to take drastic measures and basically replaced the editors of these groups. I was part of making this process happen because I was directing the Nordic Cochrane Centre at that time.

If Cochrane had been a truly open and transparent organization, it would have informed the whole world about the pretty big quality problems we had, not only in these two groups but in many groups. But they didn't, they kept it internal. I was expelled because I was criticizing that Cochrane did not always do its work well enough. I particularly criticized psychiatric drugs and Cochrane reviews about them. By far most of them were highly unreliable because they just reproduced what the drug industry had published. They thought they could solve the problem by shooting the messenger, me. But the poor quality has had consequences.

The UK National Institute for Health Research that finances the UK Cochrane group announced in April this year that it might cut its funding because Cochrane has not delivered as expected. It criticized Cochrane for very much the same reasons that I did. I summed up this process of decline in an article called “Cochrane: a sinking supertanker?” that you can find on my homepage. So, scientists and funders nowadays do not automatically see Cochrane reviews as being of high quality. They are much more sceptical than they were a couple of years ago.

Multipolar: Why don't we have an independent authority that is responsible for doing studies on drugs and vaccines? It's clearly obvious that there is a conflict of interest when a company that produces a drug or a vaccine is also responsible for proving its efficacy.

Gøtzsche: Of course. I have called for this throughout my whole career. I have used the following analogy to point out the problem: When you're accused of wrongdoing in court and you meet up in court and say, dear judge, here is the evidence. I have produced all of it myself. Now you will tell me if I'm guilty or not. This is crazy.

”It´s corruption. It's very simple.”

Multipolar: I think people should know about this because they take these studies by the companies for granted. In 2012 you described in a paper examples of serious crimes committed by each of the then ten biggest pharmaceutical companies. The crimes included marketing drugs for off-label uses, misrepresentation of research results, hiding data on harms, and Medicaid and Medicare fraud. Doctors were often complicit in the crimes. Can you explain how this corruption works in detail?

Gøtzsche: Oh, that's very simple. It is called money talks or follow the money. As I wrote in my book “Deadly Medicines and Organised Crime: How Big Pharma has Corrupted Healthcare” even in a small country like Denmark thousands of doctors are on industry payroll. They are called consultants, for example, or are sitting on advisory boards in companies. More than 1,000 Danish doctors have such a role. Do you really think that the drug industry in Denmark needs advice from more than 1,000 doctors, to such an extent that they are paid for it every year? I mean, this is corruption. They simply buy influence. And you don't bite the hand that feeds you. So, these people know very well that if they don't do what the drug industry wants, they will no longer receive this nice money. It's corruption. It's very simple.

Multipolar: Where does all the money come from? Are drugs and vaccines overpriced? Why does the pharmaceutical industry have so much power and influence?

Gøtzsche: That's a huge problem in all our democracies that the big companies are now so wealthy that they are too big to fail. Pfizer has behaved very, very badly throughout many years, but the US government has not really taken an action against them. It has just fined them, and fines are just a cost of doing business. They earn a lot more, much more money through their criminal behaviour, than they pay in fines. So, they just continue with their criminal behaviour. And if the US government should really do what is needed against Pfizer, Merck, Eli Lilly and the other big US companies, this might have pretty untoward consequences for the US economy. So, they don't do that. This is like when the mafia has become so strong that it has infiltrated and corrupted everybody, then it's too late to do anything about it.

”We need to abolish all patents on drugs and vaccines”

Multipolar: What laws or politics do we need to decrease the influence of the pharmaceutical industry again?

Gøtzsche: There is only one cure for this malady. We need to abolish all patents on drugs and vaccines, and we need to make drug development and marketing a public enterprise. Capitalism is destroying things for us in this area. This needs to be a public enterprise for the common good. We are talking about helping people to survive and not about buying a Mercedes Benz or a Porsche. This needs to be altruistic for the common good. It's totally wrong to have made this a capitalistic enterprise. As I have explained in my books and elsewhere, by far most breakthroughs in drug treatment come from publicly funded research, anyway. The big pharma companies do very little research. They more or less just extort us.

Multipolar: Emer Cooke, the current director of the European Medicines Agency (EMA), worked for the pharmaceutical industry and was a member of a lobbying organisation of the largest European pharmaceutical companies before she moved on to the EMA. Can people trust EMA's decisions on approving drugs and vaccines or should they suspect this European authority to be influenced by economic interests through the effect of the revolving door? Are there concrete hints that the latter is the case?

Gøtzsche: We can't trust our drug agencies, for many reasons. One is the revolving door phenomenon where people come from the industry and then work in EMA or FDA (US Food and Drug Administration), and then they go back to the industry again. So, if they have been very kind to the industry while they were having a job at EMA, their chances of getting a very well paid job at a major drug company, of course, will be bigger than if they have been critical. And many former heads of the FDA and EMA and other drug agencies prepared their leave by, for example, establishing a consulting company that gives good advice to companies how to get their drugs through, even though this is illegal if prepared while they still work for a drug regulator.

Multipolar: Is there a special case you can name where this happened? Can you prove that there was an approval of a vaccine or drug by EMA that was influenced by the pharmaceutical industry?

Gøtzsche: Oh, there are as many examples as you want. The main problem is that people at EMA and FDA would, of course, always say that there has been no influence from the drug industry. It's purely out of concern for the citizens that they have approved a drug that should never have been approved. The latest scandal is a huge one. The FDA approved an Alzheimer drug called Aducanumab that doesn't work at all. And the price of this drug is around $50,000 for only one patient per year.

”The ugly face of censorship”

Multipolar: When you were suspended from the position of head of the Nordic Cochrane Centre by the Rigshospitalet via pressure from the Danish Ministry of Health in 2018, the world's most cited medical researcher, Professor John Ioannidis, spoke out on your behalf in an open letter to the Danish Minister of Health. He described his fear that your dismissal would severely affect medicine, democracy, freedom of thought and justice, and around 10,000 researchers petitioned the Minister to prevent your dismissal. Where do you think we stand at the moment in terms of evidence-based political decision-making, democracy and freedom of expression, especially regarding the measures taken against the COVID-19 pandemic? What has changed in the world of medical science and healthcare politics in the last decade that most people today do not realise yet?

Gøtzsche: What we have seen during the COVID-19 pandemic is absolutely devastating. We have seen the ugly face of censorship everywhere. There is this idea that there is only one truth, and other possibilities are not allowed to be discussed. It's absolutely horrendous that people with serious conflicts of interest were allowed to write an article in The Lancet that the coronavirus did not come from the Wuhan Institute of Virology. They wrote that they stand firmly behind their Chinese colleagues, and everyone who thinks that this was not a natural infection is a conspiracy theorist. How on earth did this become accepted by the media all over the world? There was a similar article in Nature that was also horrible because they came up with some genetic arguments for why the virus had not been manufactured at the Wuhan laboratory. Later on, other scientists showed convincing data that this is very likely not correct. I have written about that in one of my articles, which I called “Made in China”.

Wearing face masks is another example. The randomized clinical trials show very clearly that face masks do not work. They have been tested in influenza, and they have been tested in Denmark during COVID-19. And yet we are commanded to look like bank robbers all over the world. This is symbolic politics of governments, so they can say that they do something. They argue that it prevents infections when you cover your mouth. But why do we do randomized trials? To find out if it’s true.

Multipolar: Why do governments order these measures? Do they listen to the wrong advisors?

Gøtzsche: In the beginning, the director of the Danish National Board of Health said that we should not use masks in Denmark, but later he changed his position. And I'm pretty sure that this was because of political pressure. When people use face masks in other countries, why not in Denmark? How could we defend that? And, of course, politicians try to do what they think will be helpful, but they have made terrible mistakes. For example, the Danish prime minister ordered that all 17 million minks in Denmark should be killed because they carried a mutation of COVID-19. It was later demonstrated that this had not been necessary because the mutation was not dangerous. I'm not commenting on whether it's good to breed minks in small cages, but that's not the issue. The issue is that our prime minister destroyed quite a big enterprise in Denmark overnight and illegally as well.

”Always follow the money”

Multipolar: Professor Ioannidis and you are highly respected scientists, but both of you have been criticized for representing “controversial” opinions. What role does influential media play in discrediting independent scientists? Why do they do that?

Gøtzsche: Always follow the money. The media thinks in terms of sensationalist stories because that will sell newspapers and TV programs. When you can throw mud at a highly respected person, it's more interesting than when you throw mud at a person who is not highly respected. That's pretty obvious. So, people like John Ioannidis and me, of course, are particularly exposed to this kind of wrongdoing. By the way, in Germany, Springer has a very dirty track record in terms of censorship. They censored our systematic review of the human papilloma virus vaccines. They tried to prevent it from ever being published.

Multipolar: What is the reason why Springer did that?

Gøtzsche: Oh, that's easy. The big publishing houses have close relations to the drug industry. In many ways. The drug industry places ads in their medical journals. They support symposia and support publishing houses and journals in other ways. And they can threaten journals and publishing houses if they publish critical articles about the drug industry by withdrawing advertisements.

Multipolar: Let’s get back to COVID-19. In the beginning of the pandemic you described most of the measures taken against the spreading of SARS-CoV-2 as panic-driven. Earlier on you mentioned that there is evidence that the pathogen was manufactured in the Wuhan Institute of Virology. The so-called gain-of-function research in Wuhan was co-funded by the EcoHealth Alliance, a non-governmental organization which itself is funded by US authorities. Do you think that the reason for the panic-like reactions of western governments was based at least on the assumption that the virus was man-made and therefore potentially much more contagious and dangerous than a natural mutation?

Gøtzsche: No. People like Peter Daszak, who is the head of EcoHealth Alliance, have fooled the whole world with no good evidence in their support. That makes it even more odd that the media didn't ask them what their evidence was. They just swallowed the bait. And so the whole world believed that SARS-CoV-2 was a natural mutation. The reason for the drastic measures ordered by our governments was that people dying in high numbers, e.g. in Bergamo in Italy, and also these scenes from Chinese hospitals where dead bodies were lying in the corridors.

”It seems we have gone way too far”

Multipolar: Do you think the measures to prevent the spreading of SARS-CoV-2 are appropriate?

Gøtzsche: The most important of all interventions is to keep distance to other people because this infection is airborne. So, it was a very good precaution to tell people to keep distance and not to have 50,000 spectators at football matches. That was very wise. But John Ioannidis published a fascinating study that showed that major lockdowns were not more effective than minor lockdowns. (1) So, it seems we have gone way too far. When the Norwegians tried to do a randomized trial in which they wanted to close only some of the schools and not all of them, it was considered unethical and they were not allowed to do it. I mean, this is the type of research that we have desperately needed, but which was never carried out.

Multipolar: In Germany children had to wear masks in school, though they were not threatened by COVID-19.

Gøtzsche: I believe this cannot be defended because COVID-19 is a mild disease in children. It seems to be milder than influenza. And we have never asked children to wear a face mask when we had influenza. And furthermore, the randomized trials have not found any effect of facemasks.

Multipolar: To protect the elderly we locked them away like prisoners, even against their will.

Gøtzsche: This is very bad. Some elderly would prefer to take an increased risk of dying of COVID-19 to see their loved ones and to hug them as they usually do because they know that their life expectancy is very short, anyway. So, this is a huge intrusion by governments into the lives of people who are close to death. We call this unsolicited paternalism. This is totally unacceptable in my view.

”I haven´t seen data yet which shows that vaccinated people have a much sooner decrease in mortality than non-vaccinated”

Multipolar: Hundreds of millions of people worldwide are currently being given injections with vaccines against SARS-CoV-2, for which the responsible authorities only granted an emergency approval. You did a review of the clinical trials for the most common vaccines from AstraZeneca, Pfizer and Moderna. Are these trials biased, and if so, in what way?

Gøtzsche: You can never trust randomized trials done by the pharmaceutical industry. But when three vaccine manufacturers come up with a result that, for instance, only one of 50 severe cases of COVID-19 infection were in the vaccine group and the 49 others were in the control group, then this is pretty strong evidence that these vaccines are highly effective. I expect these vaccines to lower mortality dramatically. There were some hints in the UK about this, but then other researchers said, it's still too early to draw that conclusion. And I have not since then seen new data that tells us that, indeed in practice, they did reduce mortality dramatically, because there are other factors that can reduce mortality dramatically. Now we are in the summer season in the Northern hemisphere, for example. I would like to see some data which shows that vaccinated people have a much sooner decrease in mortality than non-vaccinated. But I haven’t seen that, yet.

Multipolar: There is a trial in Israel which claims that the vaccinations have decreased mortality. But the decrease took place at the end of the frequent annual flu season.

Gøtzsche: You cannot call this a trial because it is not. This is just an observational study. I haven’t seen a convincing observational study that tells us that the vaccines have reduced mortality dramatically.

Multipolar: What do you think about the side effects of these vaccines? There's a discussion going on that the side effects like headaches and absence from work are not recorded properly. Could it be that the side effects could kill a lot of people as well? There are quite a few cases that prove that people also died from the vaccinations.

Gøtzsche: Well, it has always been the case that a few unlucky people could die from a vaccination. You always have to look at the other side. How many people do you save with the vaccination? But when people die who should not have been vaccinated in the first place, for example, children, then it gets very serious. When people's risk of dying is very low, for example, among children, then these few cases where a vaccine might be deadly start becoming important.

Multipolar: How do you think about the future? Do you believe that the fear of the coronavirus of the majority of the population will eventually vanish? Or do we have to live with the fact that the annual boosts of vaccinations against corona and influenza viruses will be just as much a part of our lives in the future as the regular check-ups at the dentist?

Gøtzsche: I have no idea how people will react in general, and also this is very much influenced by the media. I don't control the media, so I can't tell you, but people should not get vaccinated against influenza and I explain why in my book “Vaccines: Truth, Lies, and Controversy”. COVID-19 is a different story. It looks like repeated vaccinations may be necessary because the antibodies disappear again.

”We cannot control capitalism”

Multipolar: Last question: How can a whole population as well as individuals protect themselves against the attacks on our private life and health by the pharmaceutical industry and politicians? In your opinion, what changes of political, social or economic nature are necessary to reduce the influence of the pharmaceutical industry?

Gøtzsche: I told you in the beginning of this interview, that development of drugs, including vaccines should be a public enterprise. We cannot control capitalism. Even if we try, it will never work. It needs to be a public enterprise.

Multipolar: This means that the pharmaceutical industry has to be nationalized. People will call this communism.

Gøtzsche: Why use terms? Why not do it if it will benefit our populations the most? When drugs are the third leading cause of death after heart disease and cancer, which several studies have shown, it's pretty obvious that the current system is deeply corrupt. It kills us. So why call it communism when you want to introduce a system that saves us rather than kills us?

Multipolar: How can a system, how can politicians that are influenced by the huge power of the pharmaceutical industry act against it?

Gøtzsche: I don’t know, but they need to. If you have a rotten house, it doesn't help to call for workers to fix it. One of my neighbours did that and they repaired his house for a very long time. And then they took it all down. They should have done that in the first place because when a house is rotten, you need to remove it and built a new house. And this is exactly where we are in healthcare regarding drugs and vaccines. The house is totally rotten and we cannot save it.

Multipolar: How do you convince the majority of people that this is the case when the media is following the money?

Gøtzsche: The WHO and even the European Commission, which is quite conservative, have actually started to realize that the current system is not a good one. So, they have, for example, suggested that drug companies that develop a real breakthrough should not be allowed to patent their drug, but they should be rewarded. They should get a decent reward for their efforts and be paid off once and for all. And then we should allow other manufacturers to produce it cheaply and to sell it cheaply. I have written a paper and a follow-up article about that subject that were published by the European Journal of Clinical Investigation.

Multipolar: Thank you for the interview, Professor Gøtzsche. It was very nice meeting you.

Gøtzsche: Same here. Thank you very much for doing this work.

(1) Note of the editors 10.7.: John Ioannidis compared in his study less restrictive non-pharmaceutical interventions like voluntary social distancing and banning events with many participants with less restrictive non-pharmaceutical interventions like curfews and business closures.

Further reading:

• On the efficacy of influenza and COVID-19 vaccines (Karsten Montag, 14.6.2021)