Why Big Pharma now outsources its clinical trials overseas

In New Delhi, 49 babies died at the All India Institute of Medical Sciences (a public hospital renowned for providing low-cost treatment to the poor) while they were taking part in pharmaceutical clinical trials over a 30-month period. These babies had been given a variety of new drugs being studied to treat conditions like zinc deficiency, high blood pressure or a brain inflammation called chronic focal encephalitis. The head of the pediatrics department at the All India Institute claimed that “none of the deaths was due to the medication or interventions used in clinical trials.”

The blood-pressure drugs had never before been given to anyone under 18. Yet of the children enrolled in these studies, two-thirds of them were infants less than one year old.

As recently as 1990, only 271 drug trials were being conducted in foreign countries on drugs intended for North American use. But by 2008, that number had risen to 6,485—an increase of more than 2,000%Continue reading

10 food/bacteria combos that can make you very, very sick

I used to be a happy person. That was before I took a FOODSAFE™ course, a comprehensive safe food-handling training program developed here in the Province of British Columbia. Suddenly, newly educated, I became exquisitely aware of deadly food pathogens lurking everywhere.

Those soggy dish cloths, my Baba’s apron I wipe wet hands on, the knife used to cut (horrors!) first the raw chicken and then the green peppers, the creamy puddings left out on the counter a bit too long – each of these past sins made me nervous about eating virtually anything prepared in my own kitchen. I became just a wee bit obsessive about bleaching my chopping boards. I wondered how on earth I’d managed all those years to avoid poisoning my two children.

And don’t even start on the hidden health perils of eating out . . . Continue reading

“You can lead a cardiologist to water but, apparently, you cannot make him drink”

When it comes to interventional cardiology – that’s using balloon angioplasty* and metal stents to open up blocked coronary arteries – it seems that medical evidence is still taking a back seat to doctors’ deeply ingrained practice patterns. Case in point, a warning from the health journalism watchdogs at Health Beat:

“Even though many well-designed clinical studies conclude that drug therapy alone can reduce the risk of heart attack and death in people with stable coronary artery disease just as well as more expensive invasive procedures, many cardiologists continue to use interventions like propping open blocked arteries with costly stents instead of first trying medication.”

Or, as the Los Angeles Times put it recently in a piece called Cardiologists Rush to Angioplasty Despite Evidence for Value of Drugs:

“You can lead a cardiologist to water but, apparently, you cannot make him drink.”  Continue reading

Dr. Ben Goldacre’s rapid-fire story of the ‘Nocebo Effect’

You know, of course, about the placebo effect, in which patients report positive results from taking a mere sugar pill.  Turns out there is also something called a nocebo effect, too.  This is defined as a negative placebo effect. It happens, for example, when patients take medications and actually experience adverse side effects unrelated to any specific pharmacological action of the drug. The nocebo effect is associated with a person’s prior expectations of adverse effects from the treatment. In other words, if we expect a treatment to hurt us, cause harm, or make us feel sick – it likely will.

The U.K.’s bright and brainy Dr. Ben Goldacre of Bad Science describes this phenomenon in this short but entertaining presentation from last year’s irreverent Nerdstock tour (“Nine Lessons and Carols for Godless People).   Continue reading