Profits before people
May 9th 2008, 10:25
Those who cling to the belief that medicine is more a science than a commercial enterprise might consider the story of a group of drugs known as erythropoiesis-stimulating agents (ESAs) and their approval process.
ESAs are routinely given to cancer patients with anaemia. As they are genetically-engineered forms of erythropoietin (EPO), a protein that stimulates production of blood cells, they are the only alternative therapy to blood transfusion.
They've been in active use since their approval in 1993 - but it's only been in the last few months that researchers have started to realize that ESAs are killing the cancer patient, and are quickening tumour growth.
America's drug regulator, the Food and Drug Administration (FDA), toughened warnings about the drugs last November after studying the results of six trials that demonstrated that cancer patients given ESAs died sooner and demonstrated more rapid tumour growth than patients not on the drugs.
Coincidentally, a week or so after the FDA ruling, Amgen, a drug company that manufactures the ESA Epogen, revealed the findings of its own trial, which painted a similarly disturbing picture. Five days later, Amgen suddenly found some more data, which again confirmed the FDA's findings.
Now it's open season on ESAs. A study published last February, led by Charles Bennett of Northwestern University's Feinberg School of Medicine in Chicago, found the drugs increase the likelihood of death and venous thromboembolism.
Armed with this new data - partly provided by the manufacturer of one of the ESAs - the FDA is now considering a complete ban, or at least to dramatically reduce their usage.
None of this should come as a great surprise. Scientists were warning that ESAs would likely increase tumour growth 15 years ago, when the drugs were approved. As Bennett says: "We want to move to a more prospective approach on drug approval that is based on science and not on waiting 10 or 15 years to see bad outcomes emerge.
"In 1993, there was a science question suggesting that EPO would spur tumour growth. That needed to be evaluated from the start."
Instead, a drug was approved that scientists feared would be a killer. The drug manufacturers then adopted their customary drip-drip approach to data release on a drug that they probably also knew was a killer.
This would suggest a model that is closer to commerce than science; worse, it is one that puts its profits before people.
(Sources: Journal of the American Medical Association, 2008; 299: 2016; Journal of the American Medical Association, 2008; 299: 914-24).