When a new drug hits the market, prescribers must trust that the government has appropriately tracked all clinical trial records to ensure its safety and efficacy. The complete documentation of a medication's risks and benefits is essential to the safety of the patient, whom must additionally trust that all possible outcomes of a drug have been reported.
However, when the most prestigious research institutions violate the federal law requiring public reporting of clinical study findings, who are these prescribers and patients to trust? A recent investigation by the online medical news source STAT found that many leading universities, institutions and drug companies have failed to comply with this law,1 which is contained in the Food and Drug Administration Amendments Act (FDAAA).
This legislation was enacted to make sure all findings from human testing of drugs and medical devices were quickly made public through the website ClinicalTrials.gov, as well as through the National Institutes of Health (NIH). The requirement was driven by concerns that the pharmaceutical industry had been hiding results in an attempt to make treatments appear safer and more effective overall.
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Dangers of Nondisclosure
Robust clinical reporting is crucial because it sheds light on essential information prescribers must use to make appropriate treatment recommendations. With gaps in information being placed in the federal databases, the efficacy and safety of a treatment cannot be accurately compared to its negative side effects.
"Medical advances would not be possible without participants in clinical trials," said NIH director Francis S. Collins, MD, PhD, in a press release. "We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld."
Institutions at Fault
Although a stigma had previously been attached to drug companies for failing to report clinical trial information, the STAT investigation found that major medical schools, teaching hospitals and nonprofits reported less results overall. Included in the institutions that have failed to report their findings are four of the top 10 recipients of federal medical research funding from the NIH: the University of Pennsylvania, the University of Pittsburgh, Stanford and the University of California at San Diego, STAT reported.
According to the investigation, these researchers, university administrators and hospital executives said they were not intentionally breaking the law. Instead, they attributed their selective compliance to a lack of time and administrative funding, and the alternate disclosure of some results through medical journals and conferences.
ADVANCE Healthcare Network sought comment from Pfizer, one of the world's largest pharmaceutical companies. The company provided the following statement: "Pfizer has a longstanding commitment to sharing information and results from the clinical trials we sponsor in a transparent, accurate, fair, and balanced manner. It is our policy to submit for publication written results of interventional clinical trials, whether positive or negative."
Aside from the lack of reporting by pharmaceutical companies and research institutions, STAT noted that the FDA has the power to suspend research funding and impose serious fines on all institutions that neglect to disclose their trial results. If it had chosen to impose such sanctions, the government could have collected $25 billion from drug companies in the past 7 years. Yet, the FDA has not authorized a single fine.
"As in every FDA enforcement program, to encourage voluntarily compliance and obviate the need to take an enforcement action, whether required by statute or not, the FDA sends out a notice of potential violations. As we wait for the final rule (for FDAAA) to issue, the FDA has been working to make enforcement of FDAAA section 801 a part of the standard compliance program at each of the agency's medical product centers," the FDA said in a statement released to ADVANCE Healthcare Network.
The statement said this effort includes launching a pilot project to help develop an enforcement program that can be fully implemented after the final rule is effective. In the pilot project, the FDA evaluated 18 cases involving potential noncompliance with the FDA's submission requirements and one case involving potential noncompliance related to the failure to register an applicable clinical trial.
The FDA evaluated a total of 22 clinical trials during the pilot project because some responsible parties had more than one applicable clinical trial that appeared to be noncompliant. As part of the pilot enforcement project, the FDA issued 14 preliminary notices of noncompliance in 17 separate clinical trials to the responsible parties for those clinical trials. Several of these trials had more than 100 pages of evidence that FDA reviewed and verified to determine whether noncompliance had occurred.
Ultimately, each of the 14 responsible parties who received a notice from the FDA submitted results to the ClinicalTrials.gov databank for the 17 identified clinical trials, which eliminated the need for further action by FDA, such as sending a formal notice of noncompliance under section 402(j) (5) (C) (ii) of the PHS Act, 42 U.S.C. § 282(j) (5) (C) (ii), or filing a complaint seeking civil money penalties. In summary, when the FDAAA is finalized, the FDA will be in a better position to increase its compliance activities with regard to section 801 of FDAAA.
By increasing its amenability, the hope is that the healthcare sector will be able to better monitor compliance throughout the clinical trial processes. Furthermore, by improving the understanding and influence of these trials, errors in study conduct that could potentially cause patient harm can be avoided.
Lindsey Nolen is a staff writer. Contact: email@example.com.
1. Piller, C. Laws Ignored, Patients at Risk. STAT. http://tinyurl.com/ntykkjl