Drugs we should be concerned about

This is from the Observer (UK), December 7. I was aware of the practice, but the scope and the arrogance of the perpetrators are beyond what I knew.

Hundreds of articles in medical journals claiming to be written by academics or doctors have been penned by ghostwriters in the pay of drug companies, an Observer inquiry reveals.

The journals, bibles of the profession, have huge influence on which drugs doctors prescribe and the treatment hospitals provide. But The Observer has uncovered evidence that many articles written by so-called independent academics may have been penned by writers working for agencies which receive huge sums from drug companies to plug their products.

Estimates suggest that almost half of all articles published in journals are by ghostwriters. While doctors who have put their names to the papers can be paid handsomely for 'lending' their reputations, the ghostwriters remain hidden. They, and the involvement of the pharmaceutical firms, are rarely revealed.

These papers endorsing certain drugs are paraded in front of GPs as independent research to persuade them to prescribe the drugs. ...

Dr David Healy, of the University of Wales, was doing research on the possible dangers of anti-depressants, when a drug manufacturer's representative emailed him with an offer of help.

The email, seen by The Observer, said: 'In order to reduce your workload to a minimum, we have had our ghostwriter produce a first draft based on your published work. I attach it here.'

The article was a 12-page review paper ready to be presented at an forthcoming conference. Healy's name appeared as the sole author, even though he had never seen a single word of it before. But he was unhappy with the glowing review of the drug in question, so he suggested some changes.

The company replied, saying he had missed some 'commercially important' points. In the end, the ghostwritten paper appeared at the conference and in a psychiatric journal in its original form - under another doctor's name. ...

Dr Richard Smith, editor of the British Journal of Medicine, admitted ghostwriting was a 'very big problem' .

'We are being hoodwinked by the drug companies. The articles come in with doctors' names on them and we often find some of them have little or no idea about what they have written,' he said.

So why go to all the trouble and expense and cloak-and-dagger stuff? Is it just intra-industry competition? Or is there something more behind this? Something the drumbeat of promotion is meant to conceal? An article in the Independent (UK) for December 8 suggests there is.

A senior executive with Britain's biggest drugs company has admitted that most prescription medicines do not work on most people who take them.

Allen Roses, worldwide vice-president of genetics at GlaxoSmithKline (GSK), said fewer than half of the patients prescribed some of the most expensive drugs actually derived any benefit from them.

It is an open secret within the drugs industry that most of its products are ineffective in most patients but this is the first time that such a senior drugs boss has gone public. ...

"The vast majority of drugs - more than 90 per cent - only work in 30 or 50 per cent of the people," Dr Roses said. "I wouldn't say that most drugs don't work. I would say that most drugs work in 30 to 50 per cent of people. Drugs out there on the market work, but they don't work in everybody."

However, Roses may well have an ulterior motive in his comments.

Dr Roses has a formidable reputation in the field of "pharmacogenomics" - the application of human genetics to drug development - and his comments can be seen as an attempt to make the industry realise that its future rests on being able to target drugs to a smaller number of patients with specific genes. ...

This goes against a marketing culture within the industry that has relied on selling as many drugs as possible to the widest number of patients - a culture that has made GSK one of the most profitable pharmaceuticals companies, but which has also meant that most of its drugs are at best useless, and even possibly dangerous, for many patients.

And a marketing culture that lies and bribes its way to "hoodwinking" medical journals into becoming mouthpieces promoting more drugs to more doctors.

Footnote: Mother Jones reports that mental-health professionals know that

any given antidepressant has only about a 50 percent chance of working with any given person. But what most people - patients and clinicians alike - don't know is that in more than half of the 47 trials used by the Food and Drug Administration to approve the six leading antidepressants on the market, the drugs failed to outperform sugar pills, and in the trials that were successful, the advantage of drugs over placebo was slight. As it would hardly help drug sales, pharmaceutical companies don't publish unsuccessful trials, so University of Connecticut psychology professor Irving Kirsch and his co-authors used the Freedom of Information Act to extract the data from the FDA. What they found has led them, and other researchers who've investigated antidepressants' relatively poor showing against placebos, to conclude that millions of people may be spending billions of dollars on medicines that owe their popularity as much to clever marketing as to chemistry, and suffering serious side effects - not to mention becoming dependent on drugs for healing they might be able to do without them - in the bargain.

But many doctors remain convinced that antidepressants do work, that the flaw lies not in the capsules themselves but in the studies used to evaluate them. Clinical trials can consume half a drug's patent life. And so pressure to bring the medicine to market leads researchers to adopt strategies - such as recruiting people whose depression is too mild to yield powerful results - better suited to clearing regulatory hurdles than generating useful scientific knowledge. That, and not the power of suggestion, is why antidepressants barely outperform placebos, these scientists say.

But by their own argument, the tests did not provide "useful scientific knowledge." On what, then, do they base their confidence that the drugs themselves are actually effective? Sounds like the placebo effect works on doctors as well as patients.