By Andrew Pollack
Biotechnology drugs are supposed to be genetically engineered replicas of substances like protein that certain people otherwise lack, helping their body function as normal. But the reality does not always live up to the promise.
Some patients' immune systems attack biotechnology drugs as if they were germ. This is the case with Johnson & Johnson's anemia drug sold outside the U.S., Eprex, which is widely believed to be the cause of 141 cases of pure red cell aplasia. In this very serious condition, the body cannot produce red blood cells, making transfusions necessary. Not only was the drug ineffective, in other words, but it also contributed to anemia more drastic than before the drug. In other cases with certain biotechnology drugs, the immune response induced allergic reactions or potentially fatal shocks.
There are no solid explanations for these immune reactions. Some of the drugs are created by adding the human gene into bacteria or animal cells, resulting in a subtly different protein, and this may be a cause. Some of the drugs may be impure, or contain clumps of proteins, which can also contribute.
The manufacture of biotech drugs is not as predictable as chemical drugs, according to experts, because they rely on living cells for creation, and even the subtlest changes in the process can have unpredictable results.
The cause of the outbreak through Eprex remains unknown. The manufacturing plant in Puerto Rico is under investigation but has passed two inspections. Meanwhile, the same protein has been available in the U.S. for ten years, under the brand name Procrit by Johnson & Johnson and Epogen by Amgen, but these have resulted in relatively few cases of red cell aplasia.
Eprex and its American counterparts are a genetically engineered form of natural proteins in the body that spur red blood cell production. Prior to the biotech drug, such proteins were taken from animals or human blood and tissues to treat those lacking it, but Eprex is considered safer because it does not pose a viral risk as these methods do. Similarly, other genetically engineered drugs, such as human insulin and Factor VIII for hemophiliacs, are generally considered safer than previous methods that extracted such proteins from animals or human blood.
While the Eprex problem has stained the image of biotechnology's most successful product, major drug companies may benefit anyway. Because the manufacture of biotech drugs is not as predictable as chemical drugs, generic drug companies who have simply shown their product is identical to brand name chemical drugs in the past will likely have to go through full clinical trials before the FDA for their generic equivalents to the biotechnology drugs.
New York Times July 30, 2002
Genetically engineered, or biotech, drugs, are still in their premier stage. One of the biggest stars had been the anemia drugs Eprex, Procrit and Epogen referenced in the article.
Here's something to ponder: if, in these earliest stages, health disasters such as the 141 people inflicted with pure red cell aplasia by Eprex are already appearing, and experts are confessing they have no idea why, what nasty surprises await us as the number of these biotech drugs - and the ads pushing them -- swell in society?
The slightest variation, the minutest change, in the process of creating these proteins can have unpredictable results, experts concede. Meaning go ahead and use your imagination, anything is possible. Maybe, if some undetectable variation in the process alters them, they will only result in an allergic reaction in a handful of people. Or maybe they'll inflict irreversible damage in a far wider group of people than the Eprex disaster. It's unpredictable.
Does that inspire you to take, or let your family take, these biotech drugs?
If you are going to use biotech drugs, like all drugs they should be used with great caution and only as a last resort when you have exhausted all natural approaches.