Clinical Trial of New Breast Cancer Drug Cut Short After Benefits Found
Researchers halted a clinical trial of a new drug for breast cancer after early results indicated it could reduce by 43% the incidence of recurring breast cancer among women who'd already been treated for the disease.
According to an article in The Independent, "The reduction in risk - equivalent to one cancer prevented among 100 women treated per year - led the researchers to abandon the trial of 5,200 women halfway into its five-year term so that those on placebo could be offered the drug, called letrozole." Letrozole is one of a new class of drugs for breast cancer called aromatase inhibitors.
Full results of the trial, which was conducted in Canada, will be published in the November 6 issue of the New England Journal of Medicine.
Although Professor Ian Smith, head of the breast unit at the Royal Marsden Hospital, London, said: "This is one of the most important advances in the treatment of postmenopausal women with breast cancer, and is a further valuable step in preventing disease recurrence," he and other cancer researchers criticized the decision to halt the study early "because the long-term effects of letrozole may no/w nev/er be known.
Researchers fear it may carry risks to the bones and cognitive performance."
According to the same article, "Recent experience has demonstrated the importance of long-term studies. A US trial of tamoxifen in preventing breast cancer in high-risk women was stopped 14 months early in 1998 after results showed it cut cases of the disease by one third.
But a parallel British trial was continued for the full five years until 2001 and the results showed that the benefits of tamoxifen were almost cancelled out by an increased risk of blood clots and endometrial cancer. Tamoxifen is today not routinely recommended for the prevention of breast cancer in the UK."
For more on this story, see: http://snurl.com/1j4u.
[Comment (by Larry Trivieri, Jr (email@example.com)): So let's get this straight. A reduction in risk "equivalent to one cancer prevented among 100 women treated per year" - in other words only 1% - is deemed enough to cause a halt to a clinical trial initially designed to last for five years, thus making researchers unable to determine what potential side-effects may result from long-term use of the drug.
Is this sound science? No, but it certainly enhances the ability of the drugs manufacturers to rush the drug to market to great fanfare and huge pro/fits despite the fact that any looming dangers the drug may pose remain unknown. Imagine the wrath that would be heaped upon researchers of nonpatentable natural remedies for cancer by the various regulatory agencies if they took a similar tack.
I can see the outraged editorials in the medical journals already, not to mention the bills that would be introduced in Congress to ban such remedies outright. But for a potentially toxic drug that might harm bones and diminish cognitive function, we get, instead, a no-doubt glowing review in the prestigious New England Journal of Medicine.
Sad to say, I've heard this story before. Too many times. Once again a drug (in this case for cancer; it happens regularly for other disease too) is being touted with great fanfare, despite shoddy science. Will it actually work as it is hoped it will? Time will tell, but I wouldn't bet my lunch money on it.]
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