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.
"The current situation is a disservice to research participants, patients, health systems and the whole endeavor of clinical medicine," according to an editorial accompanying the papers published in the British Medical Journal.
Turning up the heat, the journal, in an editorial, posed a remedy that is likely to get the attention of doctors who take part in clinical trial research.
"Concealment of data should be regarded as the serious ethical breach that it is, and clinical researchers who fail to disclose data should be subject to disciplinary action by professional organizations," wrote Richard Lehman of the University of Oxford, and Elizabeth Loder, a BMJ editor.
The BMJ papers are the latest thunderbolts in a gathering storm that has swirled around medicine in recent years. The revelations add to the calls for reform in the field.
"It is grossly unethical and an insult to the integrity of medicine when this is allowed to occur and go unpunished," said orthopedic surgeon Chuck Rosen, president of the Association for Medical Ethics.
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 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.
Access to evidence
Steve Nissen, the lead author of the analysis, said 35 of the 42 studies he looked at were unpublished and were obtained only because a court case required the drug's maker, GlaxoSmithKline, to turn over the data.
"Had the medical community known about this hazard, Avandia would likely never have become the world's largest selling diabetes drug," said Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. "Our ability to provide the best care for patients is dependent on access to all of the available clinical trial evidence, regardless of whether the study showed favorable results."