Sunday, February 16, 2014

Pharma companies shouldn't conduct clinical trials: Peter C Gøtzsche

Allowing pharmaceutical companies to conduct drug trials is the equivalent of a defendant alone presenting all the evidence to determine whether he is guilty or not, argues Peter C Gøtzsche, co-founder of The Cochrane Collaboration, a global independent network of health practitioners, researchers, patient advocates and others, and author of the recently released Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare. In a candid email interview withIndulekha Aravind, Denmark-based Gøtzsche, who is a specialist in internal medicine and has also worked with clinical trials and regulatory affairs in thepharma industry, explains what motivated him to write his controversially titled book, and why we need to be wary of Big Pharma. Excerpts:

Why do you compare the business model of big pharmaceutical companies with organised crime? That's quite a strong statement to make.

I investigated the 10 biggest pharmaceutical companies in the world and found that their business model fulfils the criteria for organised crime, according to US law. Organised crime means doing the same, rather serious crime, repeatedly - this includes fraud, bribery, obstruction of justice, threatening witnesses et cetera. The industry lives up to these criteria, but only one company has been convicted of organised crime and a conspiracy. That was Pfizer, the world's largest pharmaceutical company. Since I'm a researcher and not a lawyer, I don't care that the others haven't been convicted.

I can see that they're all doing the same thing, that is, their business model lives up to the criteria for organised crime. The fines companies have to pay is a tiny fraction of what they earn from the crimes so you can't expect them to stop being criminals. In fact, economic theory predicts that the crimes will become worse, which is what we have seen.

What motivated you write this book?

I wanted to counter the pharmaceutical industry's routine excuse. When a company commits fraud through research or marketing, which then costs tens of thousands of patients their lives, the excuse is always that there are bad apples in all industries. So I decided to find out if there was just a bad apple now and then, or if the whole basket was rotten. I took the 10 biggest pharma companies in the world and Googled them, with the word "fraud". I found cases from 2007 to 2012 involving all ten companies, which had committed fraud to such an extent that it could be classified as organised crime under US law.

In India, pharma companies are shifting clinical trials abroad after guidelines were strengthened. Companies complain that the process is too tedious and steps such as mandatory audiovisual recording of consent of the subject have even been termed "ridiculous". This, they say, will increase the cost of the medicines, crucially needed in a country like India. What's your take?

We need to strengthen the criteria all over the world, not just in India, as fraud and abuse of patients in drug trials is not uncommon. This is one of the most important points in my book.

I have explained that the industry can pay for the clinical trials but should not have anything to do with it. It is as absurd as if I were a defendant in court and was allowed to provide all the evidence against myself to determine if I'm guilty or not. That's insane, right? But that is what the industry does.

Independent researchers are denied access to clinical studies when the US Food and Drug Administration (USFDA) says no to a medication. It is unreasonable considering patients are involved in the studies to further science and better treatments. The industry sees patients as a property, including data they've harvested from them, and deny the doctors who collected the data access to them! It's so horrible it reminds me of the colonial era.

You have said prescription drugs are the third leading cause of death (after heart disease and cancer) in the US and Europe. Do you think a similar situation could arise in developing countries like India as well?

It is not a matter for the future. Drugs are a leading cause of death everywhere.

What are the major reforms you would like to see in the pharma-ceutical industry that would protect the interests of patients?

Companies should not be allowed to carry out trials. They can pay for them but should have nothing to do with them. And doctors and patient organisations need to learn to say no to industry money.øtzsche-114021501019_1.html?

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