Thursday, September 12, 2013

Richard Smith: Is the pharmaceutical industry like the mafia?

Richard Smith

The piece that follows is my foreword to a new and fascinating book by Peter  Gøtzsche, the head of the Nordic Cochrane Centre, entitledDeadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare. I hope that this piece might prompt you to read the book. I was not paid for my foreword and will not receive any payment from the book.

There must be plenty of people who shudder when they hear that Peter  Gøtzsche will be speaking at a meeting or see his name  on the contents list of a journal. He is like the young boy who not only could see that the emperor had no clothes but also said so. Most of us either cannot see that the emperor is naked or will not announce it when we see his nakedness, which is why we badly need people like Peter. He is not a compromiser or a dissembler, and he has a taste for strong, blunt language and colourful metaphors.  Some, perhaps many, people might be put off reading this book by Peter’s insistence on comparing the pharmaceutical industry to the mob, but those who turn away from the book will miss an important opportunity to understand something important about the world—and to be shocked.

An emotional debate at the Danish Society for Rheumatology
Peter ends his book with a story of how the Danish Society for Rheumatology asked him to speak to the theme “Collaboration with the drug industry. Is it THAT harmful?” The original title was “Collaboration with the drug industry. Is it harmful?” but the society thought that too strong. Peter started his talk by enumerating the “crimes” of the meeting’s sponsors. Pfizer, for instance, had been fined $2.3 billion in the United States for  promoting offlabel use of four drugs, while Merck, the last sponsor, had, said Peter, been responsible for the deaths of thousands of patients with its deceptive behaviour around a drug for arthritis. After this beginning to his talk he launched into his condemnation of the industry.

You can imagine being at the meeting, with the sponsors spluttering with rage and the organisers acutely embarrassed. Peter quotes a colleague as saying that he felt “my direct approach might have pushed some people away who were undetermined.” But most of the audience were engaged and saw legitimacy in Peter’s points. In the following year all but one of the companies declined to sponsor the meeting.

Right about mammography
The many people who have enthusiastically supported routine mammography to prevent breast cancer might empathise with the sponsors—because Peter has been critical of them and published a book on his experiences around mammography. The important point for me is that Peter was one of few people criticising routine mammography when he began his investigations but—despite intense attacks on him—has been proved largely right.

He did not have any particular view on mammography when he was asked by the Danish authorities to look at the evidence, but he quickly concluded that much of the evidence was of poor quality. His general conclusion was that routine mammography might save some lives, although far fewer than enthusiasts said was the case, but at the cost of many false positives, women undergoing invasive and anxiety-creating procedures for no benefit. The subsequent arguments around routine mammography have been bitter and hostile, but Peter’s view might now be called the orthodox view. His book on the subject shows in a detailed way how scientists have distorted evidence in order to support their beliefs.

I have long recognised that science is carried out by human beings not objective robots and will therefore be prone to the many human failings, but I was shocked by the stories in Peter’s book on mammography. Much of this book is also shocking and in a similar way: it shows how science can be corrupted in order to advance particular arguments and how money, profits, jobs, and reputations  are the most potent corrupters.

Some benefits from drugs, but this book is not about benefits
Peter does acknowledge that some drugs have brought great benefits. He does so in one sentence: “My book is not about the well-known benefits of drugs such as our great successes with treating infections, heart diseases, some cancers, and hormone deficiencies like type 1 diabetes.” Some readers may think this insufficient, but Peter is very clear that this is a book about the failures of the whole system of discovering, producing, marketing, and regulating drugs. It is not a book about their benefits.

Many of those who read this book will ask if Peter has over-reached himself in suggesting that the activities of the drug industry amount to organised crime. The characteristics of organised crime, racketeering, is defined in US law as the act of engaging repeatedly in certain types of offence, including extortion, fraud, federal drug offences, bribery, embezzlement, obstruction of justice, obstruction of law enforcement, tampering with witnesses, and political corruption. Peter produces evidence, most of it detailed, to support his case that pharmaceutical companies are guilty of most of these offences.

And he is not the first to compare the industry with the Mafia or mob. He quotes a former vice-president of Pfizer, who has said:

“It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry …”

Falling foul of the US Department of Justice
The industry has certainly fallen foul of the US Department of Justice many times in cases where companies have been fined billions. Peter describes the top 10 cases in detail, but there are many more. It’s also true that they have offended repeatedly, calculating perhaps that there are large profits to be made by flouting the law and paying the fines. The fines can be thought of as “the cost of doing business” like having to pay for heat, light, and rent.

Many people are killed by the industry, many more than are killed by the mob. Indeed, hundreds of thousands are killed every year by prescription drugs. Many will see this as almost inevitable because the drugs are being used to treat diseases that themselves kill. But a counter-argument is that the benefits of drugs are exaggerated, often because of serious distortions of the evidence behind the drugs, a “crime” that can be attributed confidently to the industry.

The great doctor William Osler famously said that it would be good for humankind and bad for the fishes if all the drugs were thrown into the sea. He was speaking before the therapeutic revolution in the middle of the 20th century that led to penicillin, other antibiotics, and many other effective drugs, but Peter comes close to agreeing with him and does speculate that we would be better off without most psychoactive drugs, where the benefits are small, the harms considerable, and the level of prescribing massive.

Systematic corruption
Most of Peter’s book is devoted to building up the case that the drug industry has systematically corrupted science to play up the benefits and play down the harms of their drugs. As an epidemiologist with very high numerical literacy and a passion for detail, so that he is a world leader in critiquing clinical studies, Peter is here on very solid ground. He joins many others, including former editors of the New England Journal of Medicine, in showing this corruption. He shows too how the industry has bought doctors, academics, journals, professional and patient organisations, university departments, journalists, regulators, and politicians. These are the methods of the mob.
The book doesn’t let doctors and academics avoid blame. Indeed, it might be argued that drug companies are doing what is expected of them in maximising financial returns for shareholders, but doctors and academics are supposed to have a higher calling. Laws that are requiring companies to declare payments to doctors are showing that very high proportions of doctors are beholden to the drug industry and that many are being paid six figures sums for advising companies or giving talks on their behalf. It’s hard to escape the conclusion that these “key opinion leaders” are being bought. They are the “hired guns” of the industry.

And, as with the mob, woe be to anybody who whistleblows or gives evidence against the industry. Peter tells several stories of whistleblowers being hounded, and John Le Carré’s novel describing drug company ruthlessness became a bestseller and a successful Hollywood film.

So it’s not entirely fanciful to compare the drug industry to the mob, and the public, despite its enthusiasm for taking drugs, is sceptical about the drug industry. In a poll in Denmark the public ranked the drug industry second bottom of those in which they had confidence, and a US poll ranked the industry bottom with tobacco and oil companies. The doctor and author Ben Goldacre, in his book Bad Pharma raises the interesting thought that doctors have come to see as “normal” a relationship with the drug industry that the public will see as wholly unacceptable when they fully understand it. In Britain doctors might follow journalists, members of Parliament, and bankers into disgrace for failing to see how corrupt their ways have become. At the moment the public tends to trust doctors and distrust drug companies, but the trust could be rapidly lost.

Some solutions
Peter’s book  is not all about problems. He proposes solutions, some of which are more likely to happen than others. It seems most unlikely that drug companies will be nationalised, but it is likely that all the data used to license drugs will be made available. The independence of regulators should be enhanced. Some countries might be tempted to encourage more evaluation of drugs by public sector organisations, and enthusiasm is spreading for exposing the financial links between drug companies and doctors, professional and patient bodies, and journals. Certainly the management of conflicts of interest needs to be improved. Marketing may be further constrained, and resistance to direct to consumer advertising is stiffening.

Critics of the drug industry have been increasing in number, respectability, and vehemence, and Peter has surpassed them all in comparing the industry with organised crime. I hope that nobody will be put off reading this book by the boldness of his comparison, and perhaps the bluntness of the message will lead to valuable reform.

Richard Smith was the editor of the BMJ until 2004 and is director of the United Health Group’s chronic disease initiative.

No comments: