The Spark

“The emancipation of the working class will only be achieved by the working class itself.” — Karl Marx

FDA:
Helping out the drug companies

Dec 3, 2007

A group of U.S. heart doctors have sounded the alarm because the findings from clinical trials on two new drugs are not being released by the drug companies.

The pharmaceutical industry had “promised” to make public more information on these new medications. But they are not doing it despite a scandal two years ago prompted by patient deaths in clinical trials.

These two new medications are being prescribed to 20% of all patients on cholesterol lowering medication. When the Food and Drug Administration (FDA) approved these new drugs in 2002, the companies had only partial scientific evidence to show these drugs lowered so-called bad cholesterol (LDL) by 15 to 20%.

Current generic cholesterol lowering drugs – called statins – do more than that. Statins help calm down inflammation in arteries, preventing the build up of plaque that can cause artery blockages and lead to heart attacks.

And the statins are cheaper – available as generics costing a few pennies a day. The new drugs are 100 times more expensive.

Obviously the pharmaceutical companies involved had no interest in revealing evidence that questions the use of these new drugs. In any case, for more than two years, they sat on the results of a clinical trial. Even now, with doctors publicly criticizing them, they finally agreed to release only one quarter of the results – but not for four months.

How do they get away with it? Because the FDA lets them do it.