Evidence distortion in clinical trials

After seeing our recent post, “Seeding trials”: medical marketing disguised as science, Till Bruckner sent me this message:

I’ve been working on clinical trial transparency issues for over two years now, first for AllTrials and now for TranspariMED, and can assure you that this is only the tip of the iceberg.

This report by Transparency International, Cochrane and TranspariMED lists multiple instances in which selective and misleading reporting of clinical trials have been used by pharma companies to inflate apparent effectiveness and conceal harms (I was the lead author):
https://docs.wixstatic.com/ugd/01f35d_def0082121a648529220e1d56df4b50a.pdf

This study of mine explores case studies in which such evidence distortion has lead to patient deaths and waste of public health funds on a large scale:
https://media.wix.com/ugd/01f35d_0f2955eb88e34c02b82d886c528efeb4.pdf

Sadly, none of this is new to people working in the field of clinical trial transparency. Even more sadly, policy makers have yet to wake up to the potential public health and fiscal benefits of enacting and enforcing effective transparency rules for clinical trials.

For example, the FDA has so far failed to impose a single fine on companies that break a 2007 law requiring (some) clinical trial to publicly post their results within a year. Wider benefits aside, collecting these fines could net the US taxpayer $400 million (and counting). See:
https://fdaaa.trialstracker.net/

More on this topic can be found at:
https://www.transparimed.org/resources

I hope to read more on clinical trials by you in future. I share related news on Twitter using #AllTrials.

I asked if I could post this and he said Sure and added the above chart based on the findings of Turner et al. (2008), along with some more material:

Major new development last week:
https://www.transparimed.org/single-post/2018/09/13/New-study-shows-that-89-of-clinical-trials-run-by-European-universities-violate-transparency-rules

See also this press release:

Sanction those who fail to comply with clinical trial transparency

Quote from me [Bruckner]:

“Institutions conducting research in human volunteers should not be allowed to violate the rules with impunity. Policy makers have yet to wake up to the potential public health and fiscal benefits of enacting and enforcing effective transparency rules for clinical trials. The FDA has so far failed to impose a single fine on companies and universities that have violated the FDA Amendment Act. Collecting these fines could net the US taxpayer over $670 million in direct revenue. The indirect benefits would be far higher, because forcing the results of all trials out into the open would give us a far better picture of the real effectiveness of expensive new drugs. In many cases, new drugs are probably no better or even worse than far cheaper generic alternatives, but due to widespread evidence distortion, especially in scientific journals, doctors stilll prescribe them, and insurers still pay for them. Both patients and taxayers pay a steep price. It’s sheer madness.”

– said Dr Till Bruckner, founder of TranspariMED, an initiative to end evidence distortion in medicine

WARNING
The $670 million figure quoted above is based on FDAAA Trials Tracker data, which is updated every day. You may have to adjust the number upwards. Check quickly here:
https://fdaaa.trialstracker.net/

Some intriguing facts and figures:
https://www.transparimed.org/single-post/2018/05/08/Most-US-universities-still-lack-clinical-trial-registration-and-reporting-policies-new-study-finds

Unreported clinical trial of the week: Triamcinolone acetonide injection vs oral prednisolone for treatment of rheumatoid arthritis flare ups (2007-006729-28)


https://www.transparimed.org/single-post/2018/08/23/Continued-violations-of-key-integrity-rule-fuel-evidence-distortion-in-medicine-%E2%80%93-new-study
https://fdaaa.trialstracker.net/sponsor/national-cancer-institute-nci/

Human interest story:
https://www.theatlantic.com/health/archive/2016/01/clinical-trial-unpublished-results/423540/

Context:
https://www.statnews.com/2018/01/09/clinical-trials-reporting-nih/

And, the next day, one more item:

FDA released this just two hours ago. Hard to keep up in this field.
https://www.transparimed.org/single-post/2018/09/20/Breaking-FDA-to-sometimes-impose-fines-on-some-institutions-that-fail-to-post-clinical-trial-results

I have not had a chance to look at any of this, but I thought it could be of interest to you.

And, a few days later, after I told Bruckner that this post would be appearing in Feb, he added:

Quick word of warning: If you plan to include a $$$ figure on uncollected FDA fines, this number will have substantially increased by February, and will need updating just before you publish.
You can find the latest figure here:
https://fdaaa.trialstracker.net/