Keeping the scientists in step with societyBMJ 2007; 334 doi: https://doi.org/10.1136/bmj.39219.679248.DB (Published 24 May 2007) Cite this as: BMJ 2007;334:1079
Hardly a week goes by in the United Kingdom when the Human Fertilisation and Embryology Authority (HFEA) is out of the news. With one in seven couples having problems conceiving and greater pressure on assisted reproduction clinics to improve their success rates, together with rapid progress in research using embryonic stem cells, this is not surprising.
So the job of heading an organisation that is responsible for monitoring treatment and research in the area of assisted reproduction is a formidable one. That task has been given to Shirley Harrison, who from January this year has been chairing the HFEA as well as the Human Tissue Authority, the body responsible for monitoring the use and storage of tissue samples.
Ms Harrison will oversee the work of both authorities until, through new legislation, they merge to become the Regulatory Authority for Tissue and Embryos (RATE), expected to be in place in 2009 (see News doi: 10.1136/bmj.39222.535255.BE). A review of the 1990 HFEA Act is also due to take place, because many of today's ethical dilemmas were not anticipated when it was passed.
After taking a philosophy degree at Lancaster University, Ms Harrison worked in marketing and public relations, later taking a variety of roles in public sector organisations, while in a non-professional role she has been involved in criminal justice, education, and health. She was chief publicity officer at Sheffield City Council from 1986, where she managed the city's communications concerning the Hillsborough stadium disaster. Later she lectured on public relations at Leeds Metropolitan University, and she has written or edited two books, Public Relations: An Introduction (a standard public relations textbook) and Disasters and the Media: Managing Crisis Communications.
She was also a member of the Human Tissue Authority and its interim chairwoman before the latest appointment.
A patient herself—having had breast cancer, which is now in remission—she has been involved in several bodies that represent patients, and it is through this work that she has found her way to her present position. Among the groups she has been involved in are the National Cancer Research Network's consumer liaison group, the North Trent Cancer Research Network's consumer research panel, and the Sheffield cancer services advisory group.
Sam Ahmedzai, professor of palliative medicine at the University of Sheffield, takes some of the credit for Ms Harrison's rise to such a prominent position. He said, “My department set up the consumer research panel, where cancer patients help researchers design better studies. Three or four years ago we ran our own conference and got an influx of people—Shirley was one of them. The group was very low key, but when you get someone like Shirley coming along who is very intelligent and articulate, she ended up chairing some of our sessions.”
But Ms Harrison is not someone who overplays her personal story. Instead she uses it to inform her work.
“You use the experience you have had to inform how you explore other parts of the forest, if you like, rather than taking a personal agenda,” she said. She thought that people who pursued a personal agenda too closely discredited patients' groups in the eyes of clinicians and scientists.
Five months into the job and Ms Harrison is already overseeing some big debates. The authority is holding two consultations at present: one on multiple births after in vitro fertilisation (IVF) and one on the ethical implications of using human-animal embryos (hybrids and chimeras) in research.
The HFEA's recent proposal that doctors should be encouraged to transfer only one embryo to a patient's womb during in vitro fertilisation, instead of the more usual two, is one that worries many couples having fertility treatment (BMJ 2007;334:766, 14 Apr doi: 10.1136/bmj.39177.466701.DB). Patients fear that it will reduce their chances of having a baby, a particular worry to them given that the costs of private treatment are so high and patients often get only one cycle of IVF treatment on the NHS.
This issue has certainly been raised in the consultation on multiple births, Ms Harrison said. “If you are going to encourage patients to go for single embryo transfer, they will probably want to know that they are going to get more than one cycle. So when we launched this I wrote to the minister for public health, Caroline Flint, and drew to her attention [to the fact] that this would be an issue.
“It is not within our remit to do or even say anything about the number of cycles available on the NHS, but this reduction in the number of multiple births would be unlikely to happen if people felt they would only have one chance. It would be very difficult for clinicians and patients to come to an agreement about it.”
The HFEA is often expected to comment on issues that are connected with its work but are not within its control. However, it is the authority's ability to anticipate what researchers, the public, clinic staff, or the media might throw at it that enables it to respond promptly when called on.
One such example arose in the past few weeks, when the HFEA received applications from two couples with a history of breast cancer asking for pre-implantation genetic diagnosis.
The HFEA had anticipated that it would eventually be confronted with such requests and had already taken the step of approving the extension of embryo gene screening—from genetic mutations with 100% penetrance (those in which an individual who inherits the mutation will definitely develop the illness, such as Huntington's disease) to those with lower penetrance, such as BRCA1 and BRCA2 mutations for breast cancer, in which people with the mutation have a 50% to 80% chance of developing the disease.
Again, Ms Harrison's own experience and interest in research gave her insight into the complexity of the medical and ethical issues involved.
“I had genetic testing because of my family history. It was in its infancy [then]. Everything in this field moves so fast, and because it makes such a great story it is always the latest breakthrough in the newspapers.
“It is difficult to get across to people that these are individual cases and that you have to look at each on a case by case basis, because each will differ depending on the effect [that the genetic mutation] is likely to have through the generations.”
Using preimplantation genetic diagnosis for a wider range of diseases has brought the HFEA into conflict with disability groups, who see it as a tool that is increasingly being used to select out people with disabilities or illnesses altogether. Does she fear that embryo screening could go too fast and too far?
“Because we look at each disease on a case by case basis, I don't think we are in danger of going too fast. Always there will be opportunities to find things out in science. Just because you can do it does not mean that you should.
“That is why we have an ethics and law committee in the authority, which will look at any sort of potential for a slippery slope, for (the dreaded word) ‘eugenics' or ‘designer babies,' [and] to ensure that we are not going any faster than society is keen for us to go.”
But the HFEA has said little about another area of great public and media interest—reproductive immunology—in which, among other treatments, women are tested for antibodies to their partner's sperm and are given steroid treatments to dampen down their immune response in the hope that it will improve their chances of pregnancy.
The usefulness of the technique, which is carried out in only a few UK clinics, has been questioned by many, including the Royal College of Obstetricians and Gynaecologists, which says that evidence for its effectiveness is lacking.
On its website the HFEA says, in response to the controversy over Mohamed Taranissi's Assisted Reproduction and Gynaecology Centre and the Reproductive Genetics Institute, which were known to use such techniques (doi: 10.1136/bmj.39168.417743.DB): “There is no conclusive evidence to show that these treatments are either beneficial or ineffective.”
Ms Harrison added, “The jury is out. Nobody has yet made this 100% clear that it is better to have it or not.”
Nor is it clear that the high rate of live births in Mr Taranissi's clinics is linked to this or other factors.
Pointing out that the data from Mr Taranissi's clinic are currently being looked at, Ms Harrison said, “It is probably not helpful to discuss that clinic, but [reproductive immunology] is used in various clinics to varying degrees, and it is really not possible to say whether there is a link between its use and their success rates overall or in any particular age group.”
And because such techniques don't require an HFEA licence, the authority has no real say in whether clinics can offer them.
Such complex issues exemplify the challenges faced by an organisation such as the HFEA, where so many of the areas it regulates touch the boundaries of people's sensibilities.
It is for this reason that many doctors and scientists think that Ms Harrison is the right person to steer a rational course through the myriad of complications that the HFEA and HTA currently grapple with.
David Levy, medical director of the North Trent Cancer Network, said, “There will be difficult decisions made by the authority, and she is the sort of person that is able to stand by them. She is capable of dealing with complex ethical and emotional issues in a patient centred sort of way, and she will challenge the professionals.”
James Underwood, emeritus professor of pathology at the University of Sheffield, agreed: “Shirley is fantastic. She oozes common sense. As chair of the HTA she conducts our meetings with calm authority without being authoritarian. I am sure that her personal medical experiences motivate her to ensure that tissue based research will flourish for the benefit of future patients.”
The Best Possible Start to Life: a Consultation Document on Multiple Births after IVF is available at www.hfea.gov.uk.
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