Norman Swan: There's a significant international push for transparency upstream of pharmacy in how prescription medicines are approved for use and the completeness of the data on which these decisions are made.

You might have seen last week's Catalyst on ABC television which told the story of Tamiflu which has been stockpiled at a cost of hundreds of millions if not billions of dollars worldwide in case there's a flu pandemic.

But when researchers analysed the unpublished and raw data on Tamiflu trials, after a huge battle to have the information released (and we've covered this on the Health Report in the past), it was questionable whether Tamiflu was better than a couple of paracetamol.

At the vanguard of this call for more open data from drug trials is Professor Peter Gotzsche who's director of the Nordic Cochrane Centre in Copenhagen. He's just been here on a lecture tour.

Peter Gotzsche: We know already that we cannot trust the published literature. The drug industry has a huge financial interest in exaggerating their results and downplaying or even concealing the harms of their drugs. And even academic researchers often published results that are better than if you had looked at the data and analysed them yourself. So it's an ethical imperative that we get access to all the data, also because patients volunteer for trials to advance science, and if then the science gets manipulated you actually abuse the patients' willingness to contribute to science. So the data from trials belong to all of us, to the patients first of all and to society at large. This is also the opinion of the European ombudsman.

Norman Swan: What examples can you give of where clinical trials have been misleading or overstated?

Peter Gotzsche: Well, there are examples from all over healthcare, ranging from mammography screening to Tamiflu that likely doesn't work. For example, the COX-2 inhibitors, these are arthritis drugs that kill people because of heart attacks, the company Merck withheld cases of heart attacks, so they manipulated their trials. What they published wasn't true.

Norman Swan: Clinical trials are expensive. What do you believe should happen…so, for example, I'm a drug company, I've just done a trial of a new drug for heart disease and I'm applying to the authorities in different countries to have them approved for marketing and approved for subsidy, and I'm basing this on what's called the phase 3 trial, the final trial in the series which tells you whether it works in the defined patient group. Are you arguing that before a country approves a drug they go back to the individual patient data and reanalyse it?

Peter Gotzsche: I think they should do that, yes, but our drug regulators should not be so secretive and protect the drug companies' commercial interest. Their job is to protect the public's health, and therefore all these unpublished trials that are available at drug agencies, plus all the associated data, they should be made available to independent researchers. And also the drug industry's own individual patient data, anonymous of course so we cannot know who these people are, should be made available to anybody who asks for them.

Norman Swan: So give me an example of what's available to a drug regulator which is not available to the general public or even other researchers?

Peter Gotzsche: We applied for unpublished trials of the European Medicines Agency in 2007, and our application was rejected by the European Medicines Agency. They wanted to protect commercial interests, and we complained to the European ombudsman.

Norman Swan: This was over Tamiflu?

Peter Gotzsche: No, it was slimming pills. And it took three years before the ombudsman accused the European Medicines Agency of maladministration by not allowing us access to these data. And then the Agency simply had to give us the data. So this created a whole new policy at our European Drug Agency.

Norman Swan: And what does that policy look like?

Peter Gotzsche: We now have access to a lot of unpublished antidepressant trials, for example, even with patient data where you can read patient-for-patient what harms they experienced, including suicide attempts and so on. So we are currently analysing these data. That meant a huge progress for public health because what the companies have published about antidepressants drugs is seriously misleading.

Norman Swan: So drug regulators accept data that has not been through peer review.

Peter Gotzsche: They do that, yes, in terms of the unpublished trials.

Norman Swan: And just to explain, a drug company, a pharmaceutical company might do several trials on a new medication, but only choose some for publication.

Peter Gotzsche: Yes, exactly, and one of the examples of this is an antidepressant drug called reboxetine. Pfizer only published one trial which was positive, but there were six trials that had shown absolutely no effect, and these trials were unpublished. An industry that manipulates the data is the only party that have ever seen all the data. This is just unacceptable.

Norman Swan: But you said that the drug regulators have got access to the unpublished trials these days. Are they not analysing them along with it, so if the balance of evidence is negative or neutral they won't approve?

Peter Gotzsche: No, it's totally impossible for the drug regulators to analyse all the data they get. The FDA does some analysis…

Norman Swan: That's the United States Food and Drug Administration.

Peter Gotzsche: Yes, they do some analysis. But to analyse the whole thing they simply don't have the capacity to do this, and this is why our current system is totally broken.

Norman Swan: What's the solution to this? Because if the drug regulators don't have the resources to dissect massive amounts of data, who does? You can't do it all.

Peter Gotzsche: No, the solution is very simple actually. We must avoid the drug industry being its own judge, and we can do that very easily by saying that the drug industry should not be allowed to do trials in patients, this should be a public enterprise. And the industry could still pay for the trials but they should have absolutely nothing to do with writing the protocol, analysing the data and making all of the data available to the public. We could do trials this way and that's actually what we should do.

Norman Swan: And how do you answer the argument of the drug industry that says, well, we spent a lot of time and money developing this drug, the clinical trial gives us our competitive edge, and then everybody will find out about our drug ahead of time and we lose…even if we were willing to hand it over…but we lose our competitive edge.

Peter Gotzsche: Well, all these commercial arguments are false. If the drug industry truly had developed a breakthrough drug it would be in their interest to have an independent testing of their drug so that everybody can trust the results. In the current situation we are fooled all the time, and I usually say that the Swiss company Roche has committed the biggest crime, the biggest theft in European history with Tamiflu, which has cost billions but which likely is no better than paracetamol.

Norman Swan: Because this is the other thing that the pharmaceutical industry fears and indeed the medical profession, but what would be your estimate based on the limited reanalysis that has been done? There are thousands of drugs out there, only a tiny number have been reanalysed by people such as yourself, but based on that reanalysis, what's your guess that would be the wash-up of effective drugs that are left on the market?

Peter Gotzsche: I think we could get rid of most drugs on the market because they are likely not effective, but all drugs have harms. So my estimate is also because we use drugs that are far too expensive when we could use drugs with similar effects that are off-patent. So I can safely suggest that we could reduce our drug expenditure by more than 95% so that we use less than 5% of the money on drugs that we currently use.

Norman Swan: Somebody listening to this would say, well look, that sounds absurd. If you look at, for example, our extended life expectancy, it is likely that the extended life expectancy at middle age is due to people stopping smoking, but probably also control of blood pressure and control of cholesterol and control of type II diabetes. If you say all drugs go out, then…

Peter Gotzsche: No, that's not what I'm saying. I am saying that we could save more than 95% of our drug expenditure and yet have healthier populations. Of course we should use all these treatments that prolong life, no question about it, but in very many cases we use drugs that are at least 20 times more expensive than similarly effective drugs…

Norman Swan: Give me an example.

Peter Gotzsche: Yes, it's all over the place. Antidepressants. When citalopram from Lundbeck went off-patent, they isolated the active half of the molecule and then they sold it for 20 times as much per pill, and that was totally unnecessary to buy this because the old off-patent drug was equally effective. And we have seen the same for pills for heartburn, that cheap drugs that cost almost nothing are equally effective. We see it in hypertension, we see it in insulin treatment of diabetes, that these new very expensive insulins are actually no better than the old cheap ones. So it's all over healthcare that we are wasting money at a huge rate.

Norman Swan: And what's your opinion of the technical issues involved in having open access to this data?

Peter Gotzsche: There are some technical issues but I don't focus on these, I focus on the ethics of the whole thing. So if we agree that it is unethical to abuse patients in this way, that the data is kept secret if the drug industry doesn't like what they see, if we agree on that, the rest is just a pragmatic matter; how to make it available. This can be solved. One reason I wrote my book about crime in the drug industry and corruption of doctors is that our prescription drugs are the third leading cause of death after heart disease and cancer.

Norman Swan: That's a big call.

Peter Gotzsche: Yes, but it's true. There are studies in both Europe and America that consistently show this. So we doctors cannot handle our drugs safely, among other reasons because the drug industry hasn't told us just how harmful they are. So we kill a lot of our patients without knowing it. For example, out of heart attacks, we wouldn't know if our drug was the cause of a heart attack because so many people get a heart attack anyway. So these deaths are more or less silent, we doctors don't see them, and that's one reason why we think drugs are more safe than they really are. So therefore we should use drugs far less than we currently do.

Norman Swan: Professor Peter Gotzsche is director of the Nordic Cochrane Centre in Copenhagen.