January 17, 2012
Help us persuade Congress to reform the agency with our Action Alert!
Drug research, even from clinical trials sponsored by the federal government, is routinely suppressed, according to a new study in the British Medical Journal (BMJ), an international peer-reviewed medical publication. The study found that less than half of all NIH-funded clinical drug trials were published in a medical journal within two and a half years of the trial’s completion—with fully one-third of trial results remaining unpublished even four years after the trial. Why? Because the drug manufacturers didn’t like the data.
One example cited in the study was the FDA-approved diabetes drug Avandia, which in 2007 was found to increase heart attacks and cardiovascular deaths—even though the drug’s maker, GlaxoSmithKline, had known about the risk before the drug was approved. The BMJ study found that 35 of the drug’s 42 clinical studies had never been published, and were obtained only because a court case required the pharmaceutical company to turn over the data.
Not only does this irresponsible practice harm patients, it also increases healthcare costs. Eugene Carragee, a Stanford University orthopedic surgeon and editor-in-chief of the Spine Journal, spearheaded an unprecedented independent analysis showing that the medical device manufacturer Medtronic—not to mention a circle of orthopedic surgeons who received millions of dollars in royalties from the company—systematically failed to report serious complications with Medtronic’s bone-growth stimulating back surgery device known as Infuse. The results of a crucial clinical trial of the product were not published until nearly five years after the trial had to be halted because unwanted bone was growing around the spines of the trial volunteers.
For two years, Schering-Plough, the maker of the popular cholesterol drug Vytorin, sat on the results of a clinical trial showing that the drug provided no benefit in improving artery health. During that time, the drug was heavily marketed to consumers in TV ads; the marketing was only halted in 2008 after a congressional investigation was launched.
In 2003, a clinical trial of Multaq, a drug that treated cardiac arrhythmias, was stopped because more patients who were getting the drug were dying than those who received a placebo—though the study results weren’t published until five years later. Even so, the drug was approved by the FDA in 2009 as a treatment for atrial fibrillation in certain patients—just not as a means to reduce deaths!
Why does FDA approve drugs whose data have been suppressed by the manufacturer? Is it because FDA depends on Big Pharma for its budget—and needs drug companies to hire former FDA employees. The Wall Street Journal reported that FDA advisers, in a recent vote, said the benefits of four popular Bayer AG birth control pills outweigh the blood clot risk. What the FDA didn’t disclose is that three of the advisers have had ties to Bayer, serving as consultants, speakers, or researchers!
Despite the FDA’s bias in favor of drugs and against supplements, there are tremendous shortages of some drugs (though no shortage of supplements—so far!). This drug shortage prompts some hospitals to engage in price gouging, so a drug that usually costs $26 is being offered for $1,200. Moreover, the FDA artificially inflates drug prices—especially generic drug prices, which should be far lower than they are—as we have reported previously.
The shortage in the US drug market also makes foreign counterfeit drugs more popular. Recently, some 65 million counterfeit pills were seized in China; no word yet on how many of them had already made their way to the US.
If this is the way FDA oversees dangerous drugs, what will happen if we give them the same authority over supplements? It’s not just that the agency doesn’t have the knowledge to properly oversee supplements—they also don’t have the capacity. If they can’t keep up with the hundreds of drugs already under their purview, how will they cope with the thousands of supplements on the market? One way, of course, is for them to drastically reduce the number of supplements that can be marketed—one inevitable result of the NDI draft guidelines that we have been campaigning against.
There must be sincere and honest people working for the US Food and Drug Administration, but it is currently being run in a corrupt and incompetent way. It desperately needs to be reformed. Please help us in our ongoing campaign to overhaul the agency by signing our petition to Congress. As we say in the petition, “Everything about the FDA must be taken apart, reviewed, redefined, and re-created so that it supports, not obstructs, the mission of advancing medical science and vibrant good health for all.” Please take action today!