Since 2004, because of prescription drug scandals over deceptive marketing, unreported side effects and hidden payments to medical researchers, the gap between clinical trials and the number published has prompted reforms. However, there are still questions about how many negative results are reaching physicians and patients.
Privately Funded Drug Research
There are currently about $508 billion of privately funded drug research projects underway encompassing an estimated 50,000 clinical trials among 2.3 million patients. (Wall Street Journal, 12/12/08) Because of the vast number of commercial clinical trials, it has overwhelmed medicine's ability to independently assess and make all the results public.
Researchers, federal regulators, pharmaceutical companies and medical journals have tried to find a balance between commercial secrecy, scientific openness and the public health for over a decade. The concern has been that incomplete tests can convince doctors that the drugs being prescribed are better than a placebo, and also mislead scientists conducting follow up studies.
Reform of Clinical Trials Results
Because of the prescription drug scandals over deceptive marketing, unreported side effects and hidden payments to medical researchers that were exposed in 2004, the gap between the number of the clinical trials conducted and the number published was highlighted. In response, the Pharmaceutical Research and Manufacturers Association of America created an on-line database that summarizes clinical study results that involves hundreds of prescription medicines.
By law, comprehensive clinical data must be filed at the U.S. Food and Drug Administration (FDA) for market approval of a new drug and becomes the basis for safety information that comes with every prescription. Under a new federal law, researchers for the first time will have to post their basic results publicly on the federal online registry maintained by the National Library of Science.
The federal registry, a voluntary patient guide, has logged 65,000 studies in the last nine years. This has increased the number of registrations from 25 a week to about 350 every week. However, until September 2008, researchers only had to report the start of a clinical trial. They were no obligation to report the outcome in the registry or in a peer-reviewed journal.
Clinical Trials Results Still Lacking
Lisa Bero at the University of California in San Francisco checked 164 clinical trials testing 33 different drugs submitted to the FDA from 2001 to 2002. She found that one in four results had yet to be published. In September 2008, medical expert Ida Sim at UCSF and her associates reviewed 900 FDA filings of 90 new drugs and reported that more than half of the clinical trials were still unpublilshed 5 years after the drugs had been approved.
Penalty for Failure to Report Results
As of September, 2008, failure to report basic data about clinical test results not reported on the public registry in a timely way can cause researchers to be fined $10,000 a day and loss of their federal funding. This has increased the number of new studies to about 200 each week. However, this only covers new tests. Registry reports of serious side effects won't be required until sometime in 2009 and then the findings won't be verified.
It is expected that it will be another two years before all mandatory reporting requirements are in place at the federal registry of Clinical Trials. Whether so much data disclosure actually improves patients' well-being and the quality of care may not be known for a decade. Meanwhile, the assumption that when a drug makes it into the market place it has been properly tested and any drawbacks noted is not necessarily true.
Sources:
Pharmaceutical Research and Manufacturers Association of America
National Library of Science
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