How drug companies get the clinical trial results they want

Every prescription drug (or over-the-counter medication) in your bathroom cabinet is there because it’s been evaluated in research called a clinical trial. For a basic introduction to clinical trials, let’s turn to former editor-in-chief of the prestigious New England Journal of Medicine, Dr. Marcia Angell, who wrote the following in her frightening landmark piece called “Drug Companies & Doctors: A Story of Corruption” (New York Review of Books, 1/15/2009):

“Before a new drug can enter the market, its manufacturer must sponsor clinical trials to show the Food and Drug Administration that the drug is safe and effective, usually as compared with a placebo or dummy pill.

“The results of all the trials (there may be many) are submitted to the FDA, and if one or two trials are positive – that is, they show effectiveness without serious risk – the drug is usually approved, even if all the other trials are negative.” 

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Battling bad science

He’s back… Watch Dr. Ben Goldacre‘s irreverent and brilliant explanation of why those industry-funded miracle cure headlines can be so appallingly wrong – yes, even when the science is done by those with the letters M.D. after their names.

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How did this heart drug get approved in the first place?

In case you believe that the medicine you’re taking has been adequately tested on real live patients before being legally approved, you might want to consider research published recently in The New England Journal of Medicine*. A heart drug called nesiritide that for the past 10 years has been given to hospitalized patients with acute heart failure has failed to show any improvement compared to placebo.

But the drug had somehow received FDA approval in 2001 for use on these patients – after initial non-approval. Continue reading