Bad results in drug trials? Leave 'em out!
You're a Big Pharma giant. You've got drugs to sell. Sure, you've got to have the studies to back up your claims -- I mean, the FDA doesn't just hand out drug approvals, right?
Those trials, though -- they can be tricky, can't they? I mean, you never know if a drug is going to turn out to have nasty side effects until you start giving it to a bunch of people.
And then where does that get you? Suddenly you've put all of this money into research and development, not to mention the study itself... and it's looking like the drug isn't the miracle product you'd hoped it would be.
Guess you'll just have to go back to the drawing board and try again -- after all, you can't put a drug out there if it's not really going to help people...
Oh, come on! Why let a pesky thing like potential harms get in the way of your bottom line?
Just leave them out of the study reports, collect your FDA approval, and start raking in the dough! And as it turns out, that's exactly what's been happening.
A new study analysis, carried out by researchers at the Ottawa University Hospital in Canada, has found an alarming trend in studies of new urological treatments.
The team reviewed randomized controlled trials, all published in major urology journals in 1996 and 2004. Most of the trials were on treatments for cancer, urinary problems, or erectile dysfunction. They were looking specifically at harm reporting, using 10 criteria, such as reasons treatment would be stopped.
According to the CONSORT (Consolidated Standards of Reporting Trials) statement, which is a checklist of information experts agree should be included in trial reports, every section of a clinical trial report should include harm reporting.
They found that 72% of the trials included information on at least one adverse event. Beyond that, though, something fishy happens. A surprising 20% of the trials make no reference at all to potential harms anywhere in the article. And 18% don't put that information in the study's title or abstract.
The abstract is particularly important -- many people only look at the abstract when investigating a new treatment, and what harm that treatment can do is essential information -- and it looks like it's left out far too often.
Without information on potential harms, the researchers point out, "it is impossible to make strong recommendations for or against a treatment." So, doctors and patients are left in the dark as to whether or not a particular treatment is actually any good, and nobody is the wiser.
The story here is disturbing enough. But it gets really disturbing when you think about what it could mean for studies done on other kinds of treatments and drugs. I mean, we're fooling ourselves if we thinking this shameful behavior is limited to urology.
So, what's the answer here? Well, for a start, let's stop letting Big Pharma fund their own studies. Drug trials should be completely independent -- money is power, and it's become pretty obvious that the temptation is too great for ethically challenged pharmaceutical companies.
We've been scammed by these guys for far too long, and the cost is too great. It's time to make a change.
About the author
Christine O'Brien writes the e-letter Health eTips for Dr. Wright's Nutrition and Healing.
You can sign up for the free eTips at www.wrightnewsletter.com.

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