Use of Animals in UK Research

The UK's coalition government made reduction of the number of animals used in research a plank in its platform early on. Today, a report released jointly by the Home Office, the Department for Business Innovation & Skills, and the Department of Health purports to lay out a plan for that reduction. Indeed, the document is called, "Working to Reduce the Use of Animals in Scientific Research." The report has been greeted warmly by scientists and decried as as whitewash by animal-rights activists. This is in part because the report clarifies the government's platform position in this way:

[In] 2010, the Government made a commitment to work to reduce the use of animals in scientific research. This commitment is not focused on baseline numbers which are influenced by a range of extraneous factors. Instead, it encompasses replacement, reduction and refinement (the 3Rs) more broadly, putting them at the heart of a science-led approach.

In other words, the report contains no promises and no target numbers for animal-use reduction, but instead relies upon the 3Rs, as developed by the National Centre for the Replacement, Refinement and Reduction of Animals Used in Research (NC3Rs). The government has promised to increase NC3Rs' funding. The report contemplates a more active role for inspectors in recommending "3Rs" steps to the facilities they inspect. It also introduces a new initiative to limit use of animals by other countries via education and outreach; it mentions as an example a plan to use education to reduce the use by China of animals in cosmetic testing. Such use has been banned in the UK for 15 years; one strange result of this ban is that UK cosmetic products (such as those sold by the Body Shop) cannot be imported into China, precisely because they have not been tested on animals. The government hopes that by persuading China to alter its animal-testing standards, it can benefit animals--and also open an enormous cosmetics market to British manufacturers.

The report shows a dramatic increase in the number of procedures done on animals in recent years.

(For a Yale Bioethics/Hastings Center joint project on the use of animals in medical research, look here.)

Infertility Funding in the UK

The UK's National Infertility Awareness Campaign has published the results of its recent audit of infertility-treatment provision in the UK. The UK's own National Institute for Health and Care Excellence (NICE) recommends providing 3 full cycles to IVF to women under 40 who have not conceived after two years of unprotected intercourse or 12 cycles of artificial insemination. But the Awareness Campaign's audit shows that, for funding reasons, 73% of Clinical Consulting Groups in the UK do not offer treatment up to the NICE guideline standard. Of the 198 Clinical Consulting Groups that do offer some funding for IVF, 49% offered only one cycle and another 24% only two. Only 24% of the CCGs that fund IVF actually offer all three recommended cycles.

Three Genetic Parents?

The UK's Human Fertilization and Embryology Authority is conducting a public consultation on the question of whether they ought to permit the creation of children with three genetic parents. The question is about a new assisted reproductive technology that could prevent children from suffering from diseases carried in mitochondrial DNA. In essence, the fertility clinic would fertilize an egg, and then remove the genetic material from that egg and pop it into a de-nucleated egg from a donor. The result would be an embryo with Mom and Dad's nuclear DNA, but with mitochondrial DNA from Donor--free from any mitochondrial diseases of which Mom is a carrier.

I'm not actually bothered by this. While having three genetic parents is something new, surrogacy has given us many children with three biological parents (egg Mom, sperm Dad, and surrogate Mom--who, make no mistake, makes some serious contributions to the basic makeup and future health of the child, via hormonal and epigenetic influences, diet, gestational environment, and so on). And after all, what will we call the child of this high-tech intervention, with her three different pro-genitors?

"Baby."

Affordable Malaria Medicine in Nigeria

Here's a heartening article about a coalition that has just completed negotiations which will permit antimalarial medication to be sold in five Nigerian states (together containing about one-fifth of the population) for as little as N60.00 per dose (that's about 27 cents). Previously, Artemisinin-based Combination Therapies had sold for anywhere between N800.00 and N2000.00. The Partnership for Transforming Health Systems, PATHS2, is a program of the United Kingdom Department for International Development. The initiative is a collaboration of PATHS2 with the Clinton Health Access Initiative, Nigeria's Federal Ministry of Health, and some pharmaceutical manufacturing firms, working through the Affordable Medicines Facility for malaria (AMFm) initiative. More details on the funding mechanism are here. Malaria accounts for 70% of all disease incidence in Nigeria; in 2008 there were 57,506,430 reported cases, of which 225,424 were fatal.

Abortion Doesn't Affect Mental Health

A new study from the Academy of Medical Royal Colleges' National Collaborating Centre for Mental Health (NCCMH) finds that, while unwanted pregnancies place women at risk for mental health problems including depression, the rates of mental health problems among women with unwanted pregnancies remain the same whether they have abortions or give birth. The finding certainly undercuts anti-abortion arguments about the prevalence of "abortion regret" and the supposed negative mental-health consequences of abortion. An important question is whether it also de-legitimates the idea of "abortion for the sake of the mental health of the woman." (A Christian Medical Fellowship spokesperson is quoted making that argument near the bottom of this article.) But that's a misreading of the findings. The women in the studies that NCCMH reviewed weren't, after all, randomly sorted into "abortion" and "birth" groups. Each chose her own best all-things-considered option given the fact of the unwanted pregnancy, her own moral views, her doctor's advice, pressure she was receiving from partners or relatives, and so on. The fact that the "abortion" and "birth" groups had similar mental-health outcomes therefore certainly doesn't imply that the outcome would have remained similar if all the women who chose to have abortions had instead been denied them.

Morning-After Pill: Contrasting News

President Obama defended HHS Secretary Sebelius's decision yesterday to override the FDA's recommendation that morning-after contraceptive pills like Plan B be made available over-the-counter to women and girls of any age. Critics were accusing Obama of having directed the override in order to avoid controversy during the upcoming election. Obama today said that he wasn't in on the decision, but that he approved of it, "as the father of two daughters." As a result of the override, the drug will remain behind pharmacy counters, available without a prescription only to women over 17 years of age. Proponents of the FDA's plan saw its main advantage in putting the drug out on the pharmacy floor, where sexually active women could easily locate it, rather than in making it available to young girls; one expert observed that "not many 11-year-old girls" go into drugstores to buy anything, let alone single pills that cost $50.

Meanwhile in the UK the British Pregnancy Advisory Service is offering to make morning-after pills available free to women over 17 via post, after a preliminary telephone interview with a nurse ensures that they understand the pill's use. The charitable organization, which is the UK's largest abortion provider, is urging women to stock up in advance of the holidays, when unwanted pregnancies occur with higher-than-average frequency. The pills are sold online and in pharmacies to girls and women over 16, and are widely available, free of charge, in doctors' offices and NHS clinics.

Patient Access to Medical Records

I blogged briefly the other day about the new plan to give all NHS patients access to their own medical records online. A few more thoughts:

In the short run, making medical records available to patients will give rise to a great deal of GP/patient friction. Patients won't understand what they read, and will ask for explanation. Some patients will be shocked and offended at the way physicians have characterized them (as frightened, as uncomprehending, as unwilling to discuss certain topics, as obese, and so on). Patients may not understand why a doctor hasn't written down their whole story, or accepted their version of events. A certain number of hours will inevitably be given over to discussion of what patients find in their medical records when they are first made available. (Of course, some of this might be quite healthy--patients, for example, may well discover and correct various errors or omissions in their medical histories.) In the longer run, the availability to patients of medical records will cause doctors to write and to use them differently. Gone will be the comments on patients themselves, and the notes-to-self about options to think about trying. Medical records will become cleaner, clearer, public documents; and at the same time will become a bit less useful for doctors. For that reason, I predict, doctors will come up with other ways--perhaps even extra-legal ways, but in any case ways outside the four corners of the medical record--to note their informal impressions about patients and their families.

Patient Access to Medical Information

A group of health-related federal agencies have proposed a new regulation which would permit clinical laboratories to release test-results to patients who request them. (Currently 39 states either have no state law explicitly permitting such release to patients, or have laws mandating release only to physicians or other healthcare providers.) The current JAMA has a thoughtful analysis of some the questions raised by the new rule. The regulation is supposed to decrease physician workload, reduce the number of patients who never receive test results, and improve follow-up rates. But there are a lot of questions: will patients understand their test-results? will they experience needless anxiety over results that are abnormal but inconsequential? is it useful for patients to receive test results on their own, without medical interpretation or counseling?

Meantime, in the UK, Her Majesty's Treasury has announced in its Autumn Statement (p. 40) that all NHS patients will have online access to their own medical records by the end of this parliament (that is, by 2015). This raises a lot of questions about security and privacy, of course; but also about whether patients may be pressured into supplying their records to third parties.

Obese Child Seized by State, UK Edition

I blogged last week about the 200-pound eight-year-old who was removed from his mom in Cleveland and sent into foster care. Seems that it's not only in the US that public health officials are removing children from families who let them become too overweight. Here's an article about a five-year-old from Tameside, Greater Manchester, UK, removed from home for similar reasons; this child appears to be the youngest, but is by no means the first, to be seized from parents by UK health officials by reason of obesity.

Art Caplan has of course commented, and I have to agree: "You don't take someone out of the house and away from their parents unless they have an immediate risk of death."

Is foster care really a less expensive and more effective option than offering counseling and assistance to the child's parents?

Paralyzed Man Seeks Right to Be Killed

Tony Nicklinson, a British man who is paralyzed from the neck down as a result of a stroke, is going to court in order to challenge the law against murder. He is asking that he be permitted to have a physician euthanize him at his request. Last year's guidelines from the Director of Public Prosecutions on prosecution for assisted suicide made it clear that, while some sorts of assistance in patient suicide would not be prosecuted, "[i]t is murder or manslaughter for a person to do an act that ends the life of another, even if he or she does so on the basis that he or she is simply complying with the wishes of the other person." Mr. Nicklinson's case against the Ministry of Justice seems to be an effort to carve out a medical exception to the manslaughter/murder law. I don't expect it will succeed.

Paying Gamete Donors in the UK

The UK's Human Fertilization and Embryology Authority has just approved a major change in gamete-donor compensation policy. Previously, sperm and egg donors could be compensated up to £61.28 per day in lost earnings, with an overall cap of £250 for each donation. They could also be reimbursed for reasonable expenses, such as travel costs. Under the new regime, donors will instead receive fixed sums: £35 per donation for sperm donors, £750 per donation for egg donors. Donors who incur "excessive expenses" by, e.g., traveling long distances, will be eligible for additional reimbursement, but such expense-based reimbursement will no longer be the norm. Donors from other countries won't be eligible for travel expenses. The HFEA announcement is here. BioNews has some nice coverage. Note: these are donors for reproductive purposes. The UK doesn't pay people who donate gametes for research purposes, though a recent report from the Nuffield Council on Bioethics recommends that research egg donors be paid.