Why the FDA approves bad drugs

Cases of biased research of pharmaceutical drugs are rampant and getting worse. These are not small offenses, but problems that have caused many patients their lives.

By now, the case of Vioxx is well known. This drug, created to ease the pain of osteoarthritis and other illnesses was rushed to market using FDA data based on studies done by Merck’s own employees. Later, we found out that Merck had information before the approval process that Vioxx did cause heart-attack deaths, but they hid it from the FDA. The drug was eventually withdrawn, after causing over 88,000 heart attacks in patients, with an estimate of at least 26,000 deaths.

But the article contains many more surprises.Rezulin was marketed as a diabetes drug in the 1990s, but it was linked to 90 cases of liver failure and 63 deaths. The FDA knew of the problems since 1997 but allowed the drug to remain available until 2000. The FDA cited a favorable study in the New England Journal of Medicine as reason to keep it on the market. However, 12 of the 22 researchers involved with the study had financial ties to Warner-Lambert, Rezulin’s maker.

Surprisingly, researchers caught “red handed” are often quite brazen about their indiscretions. Dr. Charles Nemeroff, a renowned psychiatrist at Emory University, promoted a product of his own invention in a journal article in Nature Neuroscience without disclosing his financial interests. When confronted, he said he was certain the results would have been the same even if he had no financial ties to the product.

Somehow, these scientists see themselves as “absolutely objective,” as if they are beyond any human failings.

In another instance, Dr. Irwin Goldstein of Boston University collected consulting fees from drug companies while doing medical research. “Science is science,” was his excuse. “What the data shows, the data shows.”

So who loses in all of this?

You and me.

We really can’t trust the research being done on pharmaceutical drugs. Or, as the deputy editor of the Journal of American Medical Association (JAMA) says “Doctors don’t know what papers they can trust in the journals, and the public doesn’t know what to believe.”

Author by Daryl Kulak