Behind the IVF ‘trial by television’

The Human Fertilisation and Embryology Authority (HFEA) claims that its investigations into IVF clinician Mohamed Taranissi – which have been splashed across the headlines this week – are part of its important regulation of IVF treatment in Britain. It even led raids on Taranissi’s clinic on Monday, in tandem with a BBC Panorama documentary ‘exposing’ Taranissi. However, spiked has learned that there is more to this than meets the eye, and that the HFEA has been curiously heavy-handed in its dealings with Taranissi, and possibly unprofessional in its dealings with Panorama.

On Monday, the BBC’s flagship current affairs programme Panorama launched its new-look series with an attack on Taranissi. On the day the programme was broadcast, the HFEA went to court to obtain a warrant to gain entry to Taranissi’s two clinics, the London-based Assisted Reproduction and Gynaecology Centre (ARGC) and the Reproductive Genetics Institute (RGI). They demanded access and removed paper files and computers – and it all occurred in time for the incident to be reported as part of the Panorama broadcast and then later in TV news bulletins.

For all the headlines about ‘Police raids on “illegal” IVF doctor’, the HFEA-led raids (more accurately inspections) had nothing to do with any scandal uncovered by Panorama. Rather they related to an ongoing dispute between Taranissi and the regulator about the licensing of his clinics. The only link between Panorama and the HFEA’s inspections would appear to be the coincidence of timing. And some influential figures are raising grave concerns about this apparent coincidence. Dr Evan Harris MP, a member of the House of Commons Science and Technology Committee, told BBC Radio 4’s Today programme: ‘It’s extremely unusual for an investigator, a regulator, to be seen to be cooperating with journalists in terms of releasing information about one of the people they are regulating, and also to be giving interviews to that programme which is clearly an investigative journalist programme.’

The HFEA says the raids were necessary because new information has come to light and whistleblowers have come forward, and because Taranissi and his lawyers have been difficult and obstructive in response to the HFEA’s requests for information. The HFEA tells me it is unable to provide further details on this new information, or on Taranissi’s ‘obstruction’, because there is an ‘ongoing regulatory process’.

Yet the question of why the HFEA suddenly decided to raid Taranissi’s offices, in time for a sensationalist TV documentary, is a pertinent one – because the HFEA and Taranissi had, until that moment, been in fairly civil and official discussions about the licensing of his clinics.

Only last Wednesday, 10 January, Taranissi and his lawyers visited the HFEA for a Licence Committee hearing. It was part of the ongoing discussion about the renewal of his licence for the RGI, and the HFEA’s threat at the end of 2006 to revoke his licence for the ARGC. According to Taranissi and his lawyer, they believed that at the meeting they supplied the HFEA with all the information it had requested, and met the conditions laid out by the HFEA to avoid the ARGC licence being revoked and to have the RGI licence reinstated.

At no point in the meeting did anyone indicate that there might be a problem with the information supplied, Taranissi’s lawyer tells me. Indeed, Taranissi later received a letter by fax thanking him for his attendance and for the work he put into his presentations. The letter said the HFEA needed more time to analyse the information provided by Taranissi, and said that if the Licence Committee was satisfied that all outstanding information had been submitted, and Taranissi had successfully completed a Person Responsible Entry Programme, the notice to revoke the licence for ARGC would be withdrawn immediately and his application for a renewal licence for the RGI clinic reconsidered. The letter suggested that the meeting be reconvened on 5 or 7 February.

Yet the next that Taranissi heard from the HFEA was when its head of inspection turned up on his London clinic’s doorstep, with police sergeants from Scotland Yard waving a warrant to search the premises and camera crews in tow. Why was a dramatic, TV-friendly raid necessary? The lead inspector says it was because Taranissi’s clinics had failed to provide all the information, despite repeated requests. Yet given that Taranissi was at the HFEA providing information just days earlier, and understood that he would be returning there in early February, surely it would have been more appropriate to have contacted him by letter or phone pointing out the deficiencies discovered subsequent to the letter faxed by the HFEA’s Licence Committee chair on Wednesday 10 January?

This is not the first time the HFEA has been prickly with Taranissi – it has previously treated him differently to other IVF doctors. Consider the dispute over the licensing of his RGI clinic in 2005/2006.

In 2005 there was a dispute over the renewal of his RGI licence, primarily because the clinic did not provide the requisite information to the HFEA in a timely fashion. In January 2006 the HFEA notified Taranissi that the RGI no longer had a licence and that he would have to operate under Special Directions to treat existing patients until matters were resolved. However, following further negotiations and discussions, Taranissi was offered a three-year licence for the RGI in June 2006. HFEA inspector Debra Bloor wrote to Taranissi on 19 June to outline the offer of a licence.

However, the offer contained a very specific condition – namely that no ‘three-embryo transfers’ could be carried out at the centre. Taranissi duly completed the form, ticking the box to say he accepted the licence and the conditions. He also added a handwritten one-sentence note at the bottom of the form, stating that he would like to make representations regarding the special condition on three-embryo transfers attached to the licence. Taranissi says he has done this kind of thing before, on other licence offers where there was a condition he wished to challenge, and it had never been a problem.

On this occasion, though, the HFEA decided that a licence could not be provided pending Taranissi’s representations about that one condition – that is, a licence would not be provided on the basis of his one-sentence written remark. The HFEA has decreed that three-embryo transfers are too risky; its Code of Practice stipulates that licensed centres must ensure that women under 40 receive no more than two eggs or embryos; but it does allow women over 40 to be given three eggs or embryos, but no more than three.

Taranissi says he is unaware of any other clinic being forbidden by the HFEA from carrying out any three-embryo transfers, as his RGI clinic was last year. And he thought it entirely reasonable to say that he wanted to make representations about this seemingly unfair measure. Taranissi also points out that the HFEA’s Code is not actually law, and he objects to interference in his clinical judgments made in consultation with his patients.

Because Taranissi has previously accepted licence offers while commenting on certain conditions, he assumed that the licence offered by the HFEA for RGI in June 2006 was in place, and he continued treating patients. When the HFEA found out, it wrote to Taranissi on 21 July saying a licence had not been granted to the RGI and that Special Directions would be put in place to allow the continued treatment only of patients whose treatment had begun before 24 July. A Licence Committee meeting on 27 July decided that the offer of a licence to RGI should now be withdrawn, due to a change in circumstances since the offer was made.

Things then spun further out of control. The HFEA continued to pursue Taranissi over his work at the RGI, and took the extraordinary step of effectively threatening to shut down both of his clinics.

On 25 September 2006, the HFEA’s director of regulation wrote to Taranissi asking for copies of all records of treatment carried out at the RGI since 21 July. The HFEA wanted the records by 4 October. When it didn’t receive them, the HFEA upped the stakes further – deciding that it could no longer be sure that Taranissi was a suitable person to be holding a licence to carry out fertility treatment. The HFEA wrote to him on 22 November 2006 informing him that the Licence Committee had decided to propose revoking his licence at his other, primary clinic, the AGRC. In layman’s terms, they were proposing to shut him down.

As Taranissi points out, none of this had anything to do with patient safety, and certainly the controversies seem bizarre when you consider that Taranissi is one of the most successful IVF doctors in Britain. Rather, the HFEA seems to have been chasing him, and proposing revoking his licence, over matters of paperwork. Here, the regulatory, bureaucratic impulse seems to take precedence over allowing Taranissi to continue successfully and safely treating many women. And the HFEA says it represents infertile women’s interests.

It was the HFEA’s proposal to revoke Taranissi’s licence for the ARGC as well as the RGI that led to the current clashes. A letter from the HFEA’s director of regulation, dated 24 November, listed for Taranissi all the information he had to submit if he wished to keep his licence. And Taranissi and his legal team believed they were providing precisely this information at the meeting with the HFEA on 10 January, a few days before the Panorama programme and the coinciding HFEA-led raids. Taranissi’s lawyer tells me that in that two-hour meeting, they painstakingly made sure that the information in two lever-arch files handed over to the HFEA contained, as far as they could tell, everything requested.

Yet days later, the police, the HFEA and camera crews came knocking.

There are other elements about the HFEA’s relationship to Panorama that Taranissi and his lawyers are unhappy about. Such as the fact that there was a camera crew there to greet them on the morning of the 10 January meeting at the HFEA; this footage was included in the programme and reported as Taranissi attending a disciplinary hearing. The HFEA’s solicitors had written to Taranissi’s solicitors the day before the meeting, to point out that there would be members of the press outside the HFEA’s offices on 10 January; but they claimed that it was in relation to an entirely separate issue and in no way related to their attendance at the HFEA.

Taranissi and his team are also upset that Panorama was provided with information that Taranissi had no means of commenting on. Following a Freedom of Information request, the Panorama team was given information about the ARGC clinic. It related to the HFEA’s Driving Improvements report published on 8 December 2006, in which the HFEA produced a graph ranking clinics according to their ‘compliance’ with HFEA Codes of Conduct and the HFE Act. The graph listed clinics anonymously, but Panorama managed to discover the score allocated to AGRC: it was minus 29, putting it close to the bottom. Taranissi was keen to know on what basis he scored minus 29, so that he could answer Panorama’s question about his clinic’s ranking; he suspected the compliance was measured by paperwork matters rather than success or safety rates. Between 20 December and being filmed by Panorama on Friday 12 January, he requested information about the graph five times, but it was not provided.

It is hard to avoid the conclusion that the HFEA has been pursuing Taranissi for many months, rattled by the fact that he is successful, experimental and not a big fan of the HFEA’s over-cautious rules and regulations.

What will be the end result of playing these disputes out in the media and presenting Taranissi as some kind of criminal whose clinics must be invaded by FBI-style raids? Patients and potential patients may have their confidence in Taranissi shaken. And if this is undeserved, as many of Tarassini’s former patients strongly argue, it could damage the all-important relationship of trust between doctor and patient during a procedure that is already as emotionally fraught as it is clinically complicated (see In praise of the IVF ‘miracle maker’, by Cheryl Hudson).

For the HFEA, however, which has been proactive in bringing this dispute to a head in a tawdry fashion, the consequences could be rather more grave. We await the new information that apparently necessitated the HFEA-led raids on Monday 15 January. But as things stand, this public regulatory body has shown both a defensive and an authoritarian streak, as it has ensured that its frustrations with one doctor get played out in the public gaze. How can the public have confidence in a body that behaves more like a bullying prefect in a playground than an impartial regulator of national healthcare?

What all this indicates, above all, is the need for a real public debate about fertility treatment, and the kind of regulation that we might want or need. Rather than the HFEA and Tarassini slogging out a dispute through their lawyers and now the media, we should take the opportunity to have a discussion about the broader issues involved in fertility treatment – and how it can continue to be improved and access to it can continue to be widened. Do we need public regulatory bodies empowered to make such decisions, or would we be better off scrapping the HFEA and developing something less bureaucratic instead?

Now, answering that question would make a good documentary.

Tony Gilland is science and society director at the Institute of Ideas.