PSSD and Hancock’s Half Brexit

Editorial Note: The photograph is of Matt Hancock, England’s Health Secretary. The photograph below is of Guido Rasi, the director of EMA. The title echoes a famous British TV program – Hancock’s Half Hour, which over 50 years ago was must watch comedy on the BBC.  This letter was emailed and posted yesterday. There is an update detailed below. 

Matt Hancock
Secretary of State for Health for England
House of Commons
London SW1A 0AA

January 9 2019

Dear Mr Hancock

Over half a year ago, RxISK.org, which I help co-ordinate, lodged petitions with the European Medicines Agency (EMA), the Food and Drug Administration (FDA) in the USA, and MHRA here in Britain, concerning post-SSRI sexual dysfunction (PSSD), a devastating condition no-one would wish on anyone else.

Lodging these petitions was aimed at getting this not uncommon condition, first reported to the UK regulator over 30 years ago, included in the labels of antidepressants in the hope that this would minimise the horrific treatment many of those affected have had from doctors ie. being ridiculed rather than supported. We also hoped that recognition stemming from having the condition in the label might stir efforts to find a cure, thereby saving lives and marriages and maintaining trust in healthcare.

EMA, then based in Canary Wharf, and their director Professor Guido Rasi, engaged with the problem in a way that MHRA didn’t. Two months ago it occurred to me that while we had presented EMA with evidence from over 300 patients on our books affected with the problem, they might take a different approach to the issues if, in addition to our analysis of the data, they had direct access to reports from affected patients and doctors supporting those patients.

I wrote to EMA indicating I thought we could in short order get 60 patient reports and 30 doctor reports, with both patients and doctors providing their names and contact details. EMA responded that this would be helpful and asked for any material we could collect to be sent to them by the end of December. While I was aware EMA were scheduled to leave Canary Wharf, my impression was that this deadline linked primarily to preset stages in their review process rather than anything else. The email I had from them listed a Canary Wharf address with no intimation it was about to change.

We emailed over 300 people individually, telling them that by completing a form for EMA (which we supplied based on what the agency said would be helpful) and thereby indicating a willingness to be contacted, this might make a big difference. Many patients with PSSD and related conditions are very concerned about confidentiality – hence the need to email them all separately. We were not willing to take a risk with blind-copying or any other form of mass mailing.

Because of these sensitivities, we knew that many would not be prepared to take a risk engaging with EMA. We also knew that many would be deterred by an additional request we made asking them to approach their doctors to get a letter indicating at least that they existed and had at one point had an antidepressant. It would be better again if the doctor was willing to indicate they could see no other obvious explanation for the condition.

The majority of those who contacted us considered approaching their doctor. Some (in the US primarily) were not able to afford the price of a visit. Many were ridiculed by doctors unwilling to provide a letter. It’s likely that in some cases doctors are scared about supporting their patients in this way. We hope to write an article cataloguing some of the responses people had.

But we were able to get 75 reports from people in 25 countries with supporting letters from 24 doctors.

Given the holiday period and our concerns with the safety of email as a means of transmittal for confidential material, we opted to send the material by registered post to Canary Wharf on December 27. The tracking showed that it arrived safely on December 28 – although we haven’t had an acknowledgement from EMA.

The covering letter indicated to EMA that we expected more reports and supporting letters from doctors to come in during the first week of 2019. We sent this additional documentation to EMA by registered post on January 7.

This time the tracking indicated the parcel was not delivered. While I knew EMA were completing their move to Amsterdam as of the start of 2019, this was surprising.

My immediate concern was for the small number of people who had taken a risk with their privacy, both doctors and patients, but got the material to us late. The parcel will return to a central depot, where it may be opened in order to work out where to return it.

But many millions of people in the UK, and perhaps Europe, will be even more worried by the prospects for Brexit this Snafu reveals.

If the UK and EU can’t even organise a simple mail forwarding service for an important agency like EMA, where there was over a year’s advance notice of a move, what hope is there for anything else?

A further difficulty is that I can’t now be certain that Professor Rasi and those reviewing this issue have received the original tranche of materials sent to them. It is easy to imagine it as lost in the bowels of some system.

While I appreciate you have other things on your plate at the moment, I and the more than 100 people involved in this time-sensitive and privacy-sensitive issue would appreciate it if your Department could help sort this problem out.

Yours sincerely

David Healy MD
Professor of Psychiatry

Update

The letter to M Hancock was emailed to him, uploaded to the Dept of Health, and posted to him in Westminster.  It was sent at the same time to G Rasi.

We had an answer from EMA within an hour confirming they had the original package and indicating what needed to happen with the later package, whose contents would be included with the original material once it arrives.

We have yet to hear from the Department of Health.