Dozens of American doctors and patients have called for fines on companies and universities that hide clinical trial results. Over 90% of respondents to an consultation on the issue strongly supported FDA enforcement of a transparency law designed to safeguard patient interests.
Only two players urged the FDA to hold its horses: The pharma lobby group PhRMA and the medical device industry lobby AdvaMed.
Failure to report clinical trial results harms patients, undermines public health, and slows down the development of new drugs, medical devices and treatments.
Hidden clinical trial results have led to the deaths of over 100,000 patients in the United States alone, so it is unsurprising that patients, doctors, pharmacists and taxpayers were unanimous in their support for effective law enforcement:
As a survivor of a couple of cancers so far, I'm concerned about the treatments that will be offered to me if/when the other shoe drops. I'd like to have the confidence that treatments will be based on all available information, not be biased because negative trial results were allowed to be hidden from public view. It would be egregious if data could be 'disappeared' because they would reduce profits.
Martin Czigler, cancer survivor
Please start punishing those who fail to publish their trials. As a doctor I rely on the published literature to make evidence based decision. If I'm only getting half the information because the other half isn't getting published this can potentially lead to the wrong decision and harm to the public.
Michael Ostapovitch, doctor
I am a pharmacist and am called upon regularly for advice about medicines. Current evidence is skewed by the ability of interested parties to withhold trial data. This is not in the interest of patients, or wider society… Please ensure that ALL trials are registered, and that ALL trials are reported. Anything else distorts the truth.
Kurt Ramsden, pharmacist
I urge the FDA to enforce these regulations strictly so that patients, such as me, can trust the findings of clinical trials.
Paul Johnson, patient
For too long the regulators have let vested interests, mainly medicine manufacturers, avoid publishing trails which reflect badly on their product. This is totally unacceptable... As well as the unnecessary suffering this will cause patients, it will cause extra costs for the healthcare system.
John Nunney, taxpayer
Medical researchers and health experts also unanimously came out in support for fines:
Any oversight system that does not demand the reporting of ALL results fails to do its duty in the protection of human research subjects, patients and the public in general.
Dr Therissa Libby, neuropharmacology expert and associate professor
I use the clinical trials database regularly for my work and it is not uncommon to find missing or outdated information on pivotal clinical trials… Encouraging timely and accurate reporting will increase the utility of the ClinicalTrials.gov database by enhancing physicians' and potential participants' knowledge of both enrolling trials and novel drugs and devices.
Anonymous Clinicaltrials.gov user
These [clinical trials] have been done largely or substantially with public, taxpayer subsidies: Direct subsidies in publicly-funded studies, indirect tax credit and business tax deduction subsidies in privately-funded research. The results of these publicly-subsidized studies should, of course, therefore be made public… [This will enable Americans to] quit paying for procedures that have no proof of value.
William Vaughan, member of Consumers United for Evidence-based Healthcare
I am a chartered statistician [and] work as a medical statistician… I am amazed that the FDA has taken so long to get a grip on this serious ethical issue.
David Boniface, medical statistician
Only two commentators opposed stronger transparency measures: The pharma lobby group PhRMA and the medical device industry lobby AdvaMed.
This is what lobby group PhRMA had to say:
"Although civil money penalties are an important enforcement tool, PhRMA believes they should be used sparingly after educational and informal compliance efforts have failed… PhRMA thus requests that FDA clearly state that, prior to NIH and FDA completing the training and educational activities… FDA will not impose [penalties] as envisioned in the Draft Guidance… Further, PhRMA strongly recommends that FDA implement a dispute resolution procedure…
We also request confirmation that alleged non-compliance will not be stated publicly on the CT.gov website… PhRMA requests additional guidance concerning how the Agency will determine (1) whether submitted information is “false or misleading in any particular,” and (2) whether an applicant has “knowingly” submitted a false certification…"
Medical device maker lobby AdvaMed was even less enthusiastic about greater transparency:
"Information related to the device design and to the design of the trial and its endpoints for a new indication is trade secret information… AdvaMed believes FDA should avoid criminalizing insignificant deviations or exposing individuals or companies to civil remedies for them... We also do not support inclusion of clinical trial results information for applicable trials of unapproved, unlicensed or uncleared devices."
So far, the FDA has failed to collect over a billion dollars in outstanding fines that it could have imposed under existing laws.
Overall, U.S. universities have a far worse track record at reporting their trial results than large pharmaceutical companies do. One of the many weaknesses of the current FDA draft proposal is that the envisaged enforcement mechanism may bypass universities altogether. In addition, the U.S. law in question, the FDA Amendments Act (FDAAA), only covers some clinical trials.
There is no legal obligation to report the results of the many clinical trials that fall outside the scope of this law.
In contrast, the British government is currently considering cracking down on all institutions – companies and universities alike – that fail to register or reported the results of any clinical trial, across the board.
For a detailed legal and regulatory analysis of the proposal’s shortcomings, see the comment by the Collaboration for Research Integrity and Transparency (CRIT) at Yale law school. TranspariMED, AllTrials and the Treatment Action Group also submitted detailed comments encouraging the FDA to finally crack down on unreported trials.
All 63 comments submitted to the FDA are archived online. In total, 58 of the commentators strongly supported the imposition of fines by the FDA. The two industry lobby groups cited above were the only stakeholders that opposed sanctions with teeth. The remaining three commentators took no position on the question of fines. No academic institution commented on the FDA proposal.
TranspariMED will continue to monitor how the FDA’s plans evolve over the coming weeks and months. Stay tuned.