The danger of drugs … and data

A fascinating court case in Australia has been playing out around some people who had heart attacks after taking the Merck drug ­Vioxx. This medication turned out to increase the risk of heart attacks in people taking it, although that finding was arguably buried in their research, and Merck has paid out more than £2bn to 44,000 people in America – however, they deny any fault.

British users of the drug have had their application for legal aid rejected, incidentally: the health minister, Ivan Lewis, promised to help them, but documents obtained by the Guardian last week showed that within hours Merck launched an expensive lobbying effort that convinced the minister to back off.

This is a shame, because court cases can be tremendously revealing.

The first fun thing to emerge in the Australian case is email documentation showing staff at Merck made a "hit list" of doctors who were critical of the company, or of the drug. This list contained words such as "neutralise", "neutralised" and "discredit" next to the names of various doctors.

"We may need to seek them out and destroy them where they live," said one email, from a Merck employee. Staff are also alleged to have used other tactics, such as trying to interfere with academic appointments, and dropping hints about how funding to institutions might dry up. Institutions might think about whether they wish to receive money from a company like that in future. Worse still, is the revelation that Merck paid the publisher Elsevier to produce a publication.

The relationship between big pharma and publishers is perilous. Any industry with global revenues of $600bn can afford to buy quite a lot of adverts, and pharmaceutical companies also buy glossy expensive "reprints" of the trials it feels flattered by. As we noted in this column two months ago, there is evidence that all this money distorts editorial decisions.

This time Elsevier Australia went the whole hog, giving Merck an entire publication which resembled an academic journal, although in fact it only contained reprinted articles, or summaries, of other articles. In issue 2, for example, nine of the 29 articles concerned Vioxx, and a dozen of the remainder were about another Merck drug, Fosamax. All of these articles presented positive conclusions. Some were bizarre: such as a review article containing just two references.

In a statement to The Scientist magazine, Elsevier at first said the company "does not today consider a compilation of reprinted articles a 'journal'". I would like to expand on this ­statement: It was a collection of academic journal articles, published by the academic journal publisher Elsevier, in an academic ­journal-shaped package. Perhaps if it wasn't an academic journal they could have made this clearer in the title which, I should have mentioned, was named: The Australasian Journal of Bone and Joint Medicine.

Things have deteriorated since. It turns out that Elsevier put out six such journals, sponsored by industry. The Elsevier chief executive, Michael Hansen, has now admitted that they were made to look like journals, and lacked proper disclosure. "This was an unacceptable practice and we regret that it took place," he said.

The pharmaceutical industry, and publishers, as we have repeatedly seen, have serious difficulties in living up to the high standards needed in this field, and bad information in the medical literature leads doctors to make irrational prescribing decisions, which ultimately can cost lives, and cause unnecessary suffering, not to mention the expense.

It has been estimated it would take 700 hours a month to read the thousands of academic articles relevant to a GP; doctors skim, they take shortcuts, they rely on summaries, or worse. We could perform better when giving them information, but for now, it will often be "actually, I think I've seen at least two studies on that, and in different journals".

The real tragedy is that the cost of distorted information, and irrational prescribing, is far greater than the cost of the research that could prevent it. Health systems pay for these drugs – state-funded in almost every single developed country – and they largely pay for the journals, too. In a sensible world, countries would band together and pay for comparative research themselves, and the free, open distribution of the results, to prevent all this nonsense.

We do not live in a sensible world.


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The danger of drugs … and data | Ben Goldacre

This article was first published on guardian.co.uk at 00.05 BST on Saturday 9 May 2009. It appeared in the Guardian on Saturday 9 May 2009 on p10 of the Comment & debate section. It was last updated at 00.05 BST on Saturday 9 May 2009.

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