Healthy Skepticism Library item: 16247

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Broadcast

Holmes J
Total Recall
Four Corners : ABC (Australia) 2005
http://www.abc.net.au/4corners/content/2005/s1340327.htm

Abstract:

ust a few years ago they were hailed as “super aspirin” … at long last, a powerful and truly effective weapon against the debilitating pain endured by arthritis sufferers.
Now this revolutionary family of wonder drugs – the COX-2 inhibitors – is mired in controversy.
One of the most popular in the class, Vioxx – used by 300,000 people in Australia and tens of millions worldwide – was pulled off the market last October.
No one knows how many people died from strokes or heart attacks caused by Vioxx. But even in Australia, where high doses of Vioxx were never authorised, it’s feared the number of dead and injured might dwarf the toll of Australian life in the Bali bombings.
Elsewhere the toll is likely to be much higher. “It would make 9/11 look like nothing,” says a leading cardiologist in the US, where tens of thousands of litigants are lining up against the maker Merck & Co.
Now Vioxx’s most successful rival, Celebrex, and another favourite arthritis drug Mobic, have been dragged into the debate. In Australia their makers are fighting regulators’ orders to put warnings on their products.
Authorities here and in the US were aware of data pointing to the potential dangers of Vioxx as long ago as mid-2000 – only months after it hit the US market.
But Merck disputed the data, or at least its interpretation, and the regulators failed to act decisively. Instead they became caught up in lengthy negotiations that resulted only in a new warning in the fine print of the product information.
Meanwhile few doctors – and fewer patients – knew anything about the disturbing clinical data or the ensuing discussions between the manufacturers and the regulators they helped to fund.
In America, Congress is now re-examining the relationship between the regulator, the Food and Drug Administration, and the drug companies in the wake of the Vioxx debacle.
But as Four Corners reveals, few questions are being asked in Australia about the role of our regulator, the Therapeutic Goods Administration, which is entirely funded by fees from drug companies.
In this forensic account of pharmaceutical industry power and regulators’ acquiescence, Jonathan Holmes reveals what can, and did happen, when public health and private profit motives collide.