Penalties Sought for Clinical Trial Researchers who Withhold Data

A leading medical journal has found the results on an overwhelming majority of mandated clinical trials of newly-approved prescription drugs are hidden from the public.

A report from the Milwaukee Journal-Sentinel newspaper cites a series of recent studies in the British Medical Journal which slams the process of reporting results of clinical drug trials in the U.S. This practice, study authors believe, harms patients, increases the cost of health care and creates unnecessary public health risks by intentionally hiding data which highlights the dangers of a particular drug.

BMJ researchers participating in the series of studies believe physicians participating in clinical trials who either do not meet deadlines set by law or by the rules to receive federal funding should be subject to disciplinary action.

Researchers at University of Nottingham found just 22 percent of the results of mandated clinical trials on new drugs approved by the Food and Drug Administration had been submitted to the National Institutes of Health. Newly approved drugs typically carry a mandate that its manufacturer complete a post-market review of the drug and submit it to regulators.

In addition, researchers at University of Oxford found just half of the clinical trials at least partly funded by the National Institutes of Health had results published in a medical journal within 30 months of its completion. After 51 months, just two-thirds of those federally-funded trials had results published in a journal.

To back the data found in the BMJ entries, Milwaukee Journal-Sentinel and MedPageToday.com highlighted several recent cases of data suppression in which disclosing known dangers of drugs likely could have saved lives or at least avoided serious injuries or side effects. In many of the cases of clinical trial data suppression, it was negative side effects being withheld.

It noted the suppression of evidence gleaned from clinical trials on the cholesterol drug Vytorin. The study charges Schering-Plough with hiding data for two years which showed its drug carried a higher risk of injury and provided no clinical benefit to patients. Also, the heart drug Multaq was the focus of a 2003 trial that was halted early due to an unexpected number of patient deaths but the results of that study, including the fact that it was stopped early, were not disclosed until 2008.

Most recently, The Spine Journal dedicated an entire edition criticizing the disclosure of data related to Medtronic Inc.’s bone growth product Infuse, most often used in spinal fusion surgeries. The journal offered sharp criticism of Medtronic’s non-disclosure of important safety data which noted the dangers of the bone growth product, including its link to cancer and male sterility.