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http://news.independent.co.uk/uk/health/story.jsp?story=455223

 

Health Check: 'Drug companies stand to gain, but women lose out'Jeremy Laurance

20 October 2003

 

It was late afternoon when Charlotte from a PR company called. She wanted to

alert me to a drug trial that had been halted early, but could say no more until

the morning. I wondered who was paying the PR company to irritate reporters by

phoning them to tell them what they couldn't tell them. In fact, Charlotte did

have a good story, but it came with a sting in the tale that amounted to a

betrayal of women.

 

A breast-cancer drug, letrozole, had proved so effective that doctors had

abandoned a trial of 5,200 women halfway through its five-year term in order

that those on placebo could be offered it. Results of the Canadian-led study

were released early by the New England Journal of Medicine.

 

Ostensibly, this looks like good news for breast-cancer patients and, thanks to

the PR company, the story was widely reported. But what about the long-term

effects? Of course, the researchers had a responsibility to tell the women the

early results and release those who wanted to leave the trial so that they could

get the drug. But they did not have to stop it. Now, it is unlikely that any

long-term trial of the drug will go ahead.

 

The decision to abandon the letrozole trial is remarkable given what we know

about another drug trial that was abandoned early because the results were so

" good " . Tamoxifen is an established treatment for breast cancer but its role in

preventing the disease in high-risk women was unclear.

 

Two major trials were launched in the US and UK in the late 1990s, and when

there were positive results, the US trial was stopped early so that all the

women could be given tamoxifen. But the UK researchers took a different tack.

They revealed the early findings to the women but advised them to continue in

order to establish the long-term effects - and 99 per cent agreed to do so.

 

That decision was crucial because by the time the trial was completed, tamoxifen

appeared in a very different light. It did prevent breast cancers occurring, but

it also increased the rate of lethal side effects - blood clots and endometrial

cancer. These almost cancelled out its benefits, and tamoxifen is now not

generally recommended as a preventive drug in the UK.

 

So, why stop the letrozole trial so soon? Professor Ian Smith, head of the

breast unit at the Royal Marsden Hospital, said that the decision was

" unfortunate " ; Professor Jack Cuzick, head of statistics at Cancer Research UK,

said there was a trend in North America to " get a quick answer, not wait for

long-term results " . Who gains from these decisions? The drug manufacturers. Who

loses? No prizes for guessing: the women.

 

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