By BJ Bjornson
Today�s scary reading comes from McClatchy:
Drug research, even from clinical trials sponsored by the federal government, routinely is suppressed, harming patients and increasing health care costs, according to new data highlighting an ethical controversy that continues to plague the field of medicine.
. . .
From diabetes drugs to spine surgery products, scandals involving concealed data have mounted. Consider the cases of two heart drugs that were the subject of Milwaukee Journal Sentinel stories:
For two years, Schering-Plough, the maker of the popular cholesterol drug Vytorin, sat on the results of a clinical trial showing the drug provided no benefit in improving artery health. During that time the drug was heavily marketed to consumers in TV ads. The situation came to light in 2008 after a congressional investigation was launched.
In 2003, a clinical trial of Multaq, a drug that treated irregular heartbeat, was stopped because more patients who were getting the drug were dying than those who were getting a placebo. However, the study was not published until five years later.
In 2007, an independent analysis of the diabetes drug Avandia found that the drug increased heart attacks and cardiovascular deaths.
Steve Nissen, the lead author of the analysis, said 35 of the 42 studies he looked at were unpublished and were obtained only because a court case required the drug's maker, GlaxoSmithKline, to turn over the data.
Drug companies may have been the focus of most of the criticism, medical device makers also come in for their share of suppressing data, particularly Medtronic, where a paper written by several surgeons receiving millions in royalties from the company failed to publish a the results of a clinical trial showing problems with a bone-growth stimulating product.
And lest it be said that it is only the companies themselves keeping vital data out of the light, government-funded research isn�t faring much better.
A surprising finding in the BMJ analysis was that serious lapses occurred even in clinical trials funded by the National Institutes of Health.
That research showed that less than half of NIH-funded clinical trials were published in a medical journal within 30 months of the completion of the trial and after 51 months, one-third of trials remained unpublished.
. . .
A second BMJ paper looked at clinical trials of drugs that already had received at least one Food and Drug Administration approval. In such cases a law requires the reporting within one year of the completion of the trial.
Despite the law, only 163 of 738 such trials, or 22 percent, had reported the results within a year, the paper found.
Makes you feel all warm and fuzzy inside, doesn�t it?