Jul 22, 2002
Drug maker Johnson & Johnson is facing a criminal investigation at its Puerto Rican factory, which makes Eprex. Eprex is a drug taken to increase the red blood cells in people on kidney dialysis or in people with anemia due to chemotherapy.
The Eprex from the Puerto Rican factory is sold in Europe, where concern is growing because 141 Eprex users have developed aplasia. These patients were taking Eprex to increase their red blood cells. Instead, it seems to have destroyed their red blood cells, leaving some with the possibility of needing blood transfusions for the rest of their lives. In other words, a drug designed to improve their situation seems to have made it worse.
However, the investigation in Puerto Rico does not stem from these incidents of aplasia, for which health authorities have no explanation as yet. It comes from a lawsuit filed by a worker dismissed from the Puerto Rican plant after working there 10 years. In his lawsuit, the worker has documented more than 100 incidents of the company ordering workers to falsify records. Hector Arce, the fired worker, was one of the people ordered to falsify records.
Eprex is a big seller for Johnson & Johnson and Amgen, its original developer, bringing in more than five billion dollars a year for the two companies. It is one of the best-selling drugs in the world. These cases of aplasia have only appeared in the last few years and only in the version of the drug sold in Europe.
But the problems began to appear after Johnson & Johnson made some changes in manufacturing. Nobody knows at this point whether those changes are causing a reaction in patients that is the opposite of what it ought to be. But it has led to one death.
So what has the manufacturer done to solve these problems? Well, they certainly claimed there was “no connection” between the illnesses of Eprex users and the firing of a worker who was about to talk to the FDA about possible manufacturing violations. But companies always claim they are innocent until proven otherwise.
In how many other cases have drug users been the victims of drugs not tested sufficiently or manufactured under less than sanitary conditions? The example of HRT, estrogen pills, has just made the news. But it was hardly the first drug to harm those it was supposed to help.
Johnson & Johnson worries when its stock price goes down, due to news like the problems with Eprex. But it doesn’t worry enough to shut down the plant and find out what is wrong – because that would cost them money.