Target: Dr. Stephen Ostroff, M.D., Commissioner of Food and Drugs
Goal: Fine medical research institutes that misinform doctors and risk patients’ lives by failing to report results.
Medical institutes which conduct human clinical trials are required by federal law to report results of said trials to the National Institute of Health. Several top medical research institutes, such as Stanford, the University of Pennsylvania, University of Pittsburg, and Memorial Sloan Kettering Center are failing to report their findings, or doing so far past the deadlines, causing professionals of the medical community to be misinformed about potential dangerous side effects and potential mortality rates of medical treatments.
Congress passed the law requiring reports of clinical trials in order to protect patients. Unfortunately, even though this is a federal law, 95 percent of findings have either failed to be reported on, or were submitted well past the deadline. This has harmful or often deadly consequences for patients. One example is the disputed breast cancer treatment Avastin, which was so harmful during clinical trials that the study was not even completed; however, the University of Indiana researcher failed to report this, and Avastin was used in other medical institutions for several years afterward. The patients who were treated with Avastin for years after the discontinued clinical trial are victims of the researchers’ negligence.
The Food and Drug Administration should be enforcing the fines they are empowered to implement. Medical institutes can be fined up to $10,000 per day for each late report. STAT claims that over the past seven years, the FDA could have collected $25 billion, and the fact that these fines are not currently enforced is contributing to the further lack of reporting. These medical institutes should be held responsible for the research they are conducting instead of being in the pockets of the pharmaceutical companies who are trying to push their products.
By signing the petition below you will help urge the Commissioner of Food and Drugs to enforce the fines these medical institutions owe due to their lack of reporting essential information. Patients can no longer be the victims of medical misinformation.
Dear Dr. Ostroff,
In order to prevent pharmaceutical companies from selling harmful products, medical institutes which conduct human clinical trials are required by federal law to report findings within a year of study completion. Recently, it has been found that approximately 95 percent of clinical trial results are reported either late, or not at all, leading to misinformation among medical professionals, and patients receiving treatments that are proven to be harmful.
Over the past seven years, the FDA could have collected about $25 billion in fines from medical institutes for late reporting or failing to report results of human clinical trials. Not only does this failure to collect on fines encourage medical institutes to continue to report late or not at all, but it also contributes to misinformed medical professionals and patients who continue to use dangerous medical treatments.
I am urging you to enforce the fines on the medical institutes who have failed to report the data of their clinical trials. Please take actions to enforce policies that will prevent members of the medical community from being misinformed, which could lead to higher patient mortality.
[Your Name Here]
Photo Credit: Multidisciplinary Association for Psychedelic Studies