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.” 

Continue reading

“I’m not a real doctor – but I play one on drug ads”

You may recall seeing Dr. Robert Jarvik‘s pleasant face on your TV screen a few years ago flogging Lipitor, the biggest-selling drug on the planet at that time, earning well over $12 billion a year for Pfizer – the biggest drug company on the planet.

This partnership emerged just as the company was seeking to protect Lipitor from emerging competition by cheaper generics, and just before a U.S. Congressional investigation started looking into Jarvik’s credentials and his controversial role as paid pitchman for the cholesterol-lowering statin drug. Continue reading

How a new drug gets approved

alarm clock boyPity the poor schmuck who has no trouble falling asleep at bedtime, but is then wide awake in the middle of the night, staring bleakly at those evil green numbers on the clock radio for the next four hours. Have you been there yourself?  What if there were a magical pill we could take in the middle of those nights that would help us drift off to sleep again for just a few more hours until morning?

Enter the drug Intermezzo, a potential treatment for people suffering from this specific form of insomnia that involves difficulty falling asleep after waking up in the middle of the night.  Continue reading