1 Boring Old Man

In a recent discussion about the origin of the chemical imbalance notion of depression [see guilding the lily…], I mentioned a BMJ Editorial by David Healy [available online]…

• Serotonin and depression: The marketing of a myth
  ^{British Medical Journal; by David Healy; April 21, 2015.}

• Author’s reply to Langford, Cowen, Chekroud and Krystal
  ^{British Medical Journal; by David Healy; May 14, 2015.}

I wrote an almost identical editorial in 1991. Covering the marketing of serotonin in 1997, I cited Jerome Gaub’s 1767 opinion of Leibniz’s views on the relations between mind and body—it is a “fable whose novelty has recommended it, whose recommendation has spread it, whose spread has polished it, refined and adorned it with … a pleasing look of truth.”

I use selective serotonin reuptake inhibitors [SSRIs]. Nevertheless I believe the SSRI era will soon stand as one of the most shameful in the history of medicine. The shame does not stem from what drug companies have done, which is only what might have been expected, but from the failure of doctors to know as much as they should have done about drugs they dish out so liberally. A recent study showing how a dollop of neuroscience dressing can disguise otherwise meaningless material should be compulsory reading for doctors who are, after all, the true consumers of these drugs.

But perhaps an even greater shame will be seen to lie with the fact that, during this era, most publications on on-patent drugs in our best journals were ghost-written. In addition, during this time journals refused to demand access to trial data as the price for publication — this is most clearly demonstrated in the area of antidepressant studies on children. It has been an era when industry has controlled journals, by spending money on some of them and by intimidating others.

The BMJ requires data sharing on request for all trials

by Elizabeth Loder and Trish  Groves

British Medical Journal. 2015 350:h2373

Heeding calls from the Institute of Medicine, WHO, and the Nordic Trial Alliance, we are extending our policy. The movement to make data from clinical trials widely accessible has achieved enormous success, and it is now time for medical journals to play their part. From 1 July The BMJ will extend its requirements for data sharing to apply to all submitted clinical trials, not just those that test drugs or devices. The data transparency revolution is gathering pace.2 Last month, the World Health Organization [WHO] and the Nordic Trial Alliance released important declarations about clinical trial transparency.

These announcements come on the heels of the US Institute of Medicine’s [IOM] report on sharing clinical trial data, which called for a transformation of existing scientific culture to one where “data sharing is the expected norm.” The efforts of industry, too, must be acknowledged, some of which caught many people by surprise. In particular, Medtronic’s cooperation with the Yale University Open Data project and GlaxoSmithKline’s leadership on data disclosure efforts stand out.

WHO’s statement on public disclosure of clinical trial results and the accompanying rationale reiterate the organisation’s support for registration of clinical trials. WHO declares that the main results of clinical trials should be posted on a clinical trial registry or other acceptable website and submitted for journal publication within a year of study completion. The expectation is that results will be “made available publicly at most within 24 months of completion.” The statement does not call for mandatory sharing of primary data from trials but instead “encourages” sharing of research datasets “whenever appropriate.”

In a move that is particularly welcomed by Ben Goldacre, cofounder of the AllTrials campaign, WHO also recommends disclosure of previously conducted but unreported clinical trials in a searchable and free registry and says it is “desirable” that these trials should be published in a peer reviewed journal. Goldacre notes that this is important because “the overwhelming majority of prescriptions today are for treatments that came onto the market — and were therefore researched — over the preceding decades rather than the past five years”…