Signs Future Clinical Trial Data Will be Transparent

In December of 2012, the BMJ announced a new policy regarding the sharing of data from clinical trials that included that BMJ would not publish material for trials on drugs and medical devices unless the authors committed to making the relevant anonymised patient level data available on reasonable request.
This was to apply to any paper that reported endpoints of a randomised controlled trial of one or more drugs or medical devices in current use, whether or not the trial was funded by industry.

Thus began the first genuine attempt to create transparency and prevent the systematic fraud that had permeated the entire pharmaceutical industry.

Academics regard publishing of their work in prestigious journals as a gold standard and the primary currency for advancement.
The long road back to honest publication is thus marked by this BMJ change in policy.

Hidden clinical trial data are systematically undermining health practitioner abilities to prescribe treatment with confidence.
A whole range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people’s lives and wasting public money.

In December 2011, the Friends of Science in Medicine (FSM) was formed against a backlash that was forming around the widespread falsification of clinical data and it was thought that this organisation would spearhead Australian attempts to help rectify this problem, given the title and composition of the group.
How wrong we were.

Disappointingly, it concentrated on harassing chiropractors by pressuring universities to drop support for chiropractic courses and campus clinics.
Latterly, attention has turned to homeopaths and a campaign to eliminate them from any form of subsidised funding.
They are giving an impression of diverting public attention from the real issues that involve mainstream drugs and misuse of public funds by the sponsors of these drugs on our PBS.

FSM claims to have 1000 members spread across all states of Australia with representatives from most of the health professions, including pharmacy.
The original intake of members was Emeritus Professors, Professors or Associate Professors, numbering 70 percent of the initial membership.
Seemingly, the organisation relies on individual reputation and anecdotal one-liners to spearhead its policies.
There is little evidence or rationality to back the bullying of relatively minor health players, while doing nothing to improve the standard of evidence generally emanating from the collective academia housing the professors, that may have contributed to the false evidence databases in the first place.

Who benefits?

The BMJ emailed 683 corresponding authors of trials published in the six major general medical journals.
About three quarters of the 317 who responded said that they thought data sharing through data repositories should be required, and a similar proportion said that data sharing should be required in response to individual requests.

The policy has clear limitations and is by no means the end of the story. The BMJ publishes relatively few trials of drugs and devices.
Of the 226 research papers published so far in 2013, 31 were the main reports of randomised controlled trials, of which most were trials of health services.
Six trials were of drugs, none were of devices, and only one of the drug trials was sponsored by industry. 
The BMJ’s new policy is a signal, but it won’t change things on its own.
The Annals of Internal Medicine and PLoS Medicine now have policies on data sharing. 
It is hoped that other journals will follow, and that the International Committee of Medical Journal Editors, of which the BMJ is a member, will take a decisive lead.

Data sharing and formal data-sharing repositories are considered a major innovation to tidy up the pharmaceutical industry.
Now here is a project that might give FSM some positivity and create a credibility level that can be respected.

But because many trials never get published in journals at all, real change will come only when the regulators raise their game.
Here too there is scope for optimism.
After pressure from the Nordic Cochrane Centre, the European ombudsman ruled that the European Medicines Agency (EMA) had been wrong to hold clinical trial data as commercial in confidence.
The agency’s new director general responded by announcing earlier this year that the agency would publish clinical trial data once a drug has been approved.
A re-analysis of this data could be undertaken 
A workshop this week aims to hammer out the details.

If patient anonymity is assured, the most efficient and effective option must be open deposition of patient level data with the underlying code and background documentation.
However, many practical problems are still to be resolved.
All the signs are that the initial approach will fall short of this ideal, with a focus instead on availability on request.
Contracts will therefore need to be agreed between data “owners” and “requesters”, and those contracts have the capacity to introduce restrictions and constrictions.
These new policies are at least a step in the right direction.
The first substantial target is to achieve proper independent scrutiny of trials of all drugs and devices in current use.
Journals and their contributors will now have to ensure that there is as rigorous in overseeing and critiquing this new breed of re-analyses as has occurred with new originals.

More recently, Members of the European Parliament have voted overwhelmingly in favour of introducing a raft of legal measures to increase the transparency of clinical trials in Europe.

From 2016, when the new clinical trials law is expected to come into force, all trials will have to be registered on a publicly accessible EU clinical trials register before they can begin, and a summary of the trial results will be required to be posted within a year of the end of the trial, along with a lay summary for the general public.
This will apply prospectively, so will not solve the problem of unpublished data on drugs in use now.

Concurrently, another step toward retrospective access to data was made as AbbVie, one of two US drug companies that took legal action against the EMA to try to stop it releasing clinical trial data, has dropped its lawsuits.
It’s possible that we may all, one day, be on the same page when talking about clinical trials and evidence-based medicines.
If the Friends of Science in Medicine ever decide to become part of the solution (rather than a diversion) then they will be welcomed.

Other health modalities do not appear to be corrupt in the sense of ripping off patients (as implied by FSM). They may have a different base for developing their evidence but I believe that the average consumer today has a high enough level of intelligence to understand what they are agreeing to.

If they want to march with their feet to alternate medicine and therapies then that is their prerogative.
The FSM does not do my thinking for me, nor dare I say, the 70 percent of Australians already enjoying the benefits of complementary medicines.

Leave a Reply

Your email address will not be published. Required fields are marked *