Taking the popular over-the-counter pain and fever medication paracetamol during pregnancy might affect the unborn child more than we assumed – and hoped for. Recently, research began to link pre-natal exposure of paracetamol (also known as acetominophen) to asthma and poor motor and communication skills in small children. Now, a new study published yesterday suggests that taking paracetamol during pregnancy comes with an increased risk for the baby of developing attention deficit hyperactivity disorder (ADHD) later.
The authors of this study investigated 64,322 Danish children (born 1996-2002) and their mothers. The women were asked whether they have taken paracetamol in computer-assisted telephone interviews three times during their pregnancy and shortly after. To asses ADHD in children, the researchers used different ways: they asked the mothers of 7-year-olds about their child’s behaviour using a standardised ADHD questionnaire. Moreover, they used Danish medical registries to gain information about diagnoses of hyperkinetic disorder, which resembles a severe form of ADHD, and descriptions of ADHD medication to the children.
In the U.K., a Labour plan has recently been in the news and stimulating some interesting debate – mainly about the over-regulation of smoking.
As can be seen on the BBC news website, Labour peers have “tabled an amendment to the Children and Families Bill detailing their proposal for England, which they said was about “protecting children”. Lord Hunt, who supports the motion, has stated
“Some Lords will argue a car is a private space and that we should not legislate for what happens within such a space. But there are more important principles than that… For one for me is the need for child protection. Unlike most adults, children lack the freedom to decide when and how to travel, they lack the authority most adults have to ask people not to smoke in their company. And in those circumstances I think it is right for Parliament to step in to protect children.” Continue reading
U.S. President Barack Obama’s recent interview in the New Yorker was surprisingly interesting. While some have noted his disapproval towards a (hypothetical) son playing pro football out of concussion concerns, the more remarkable comments concern marijuana: he says it’s “not very different from…cigarettes” and “I don’t think it’s more dangerous than alcohol.” He did not come out in favour of legalisation, however, and this makes his views (and, to a certain extent, the position of the executive branch charged with carrying out federal law) incoherent – by which I mean, his various positions taken together are inconsistent. Obama may well ‘evolve’ further as he did with gay marriage, but any such evolution will likely come too late in his term to lead to an effective, permanent change in policy. Continue reading
Kyle Edwards, Uehiro Centre for Practical Ethics and The Ethox Centre, University of Oxford
Caroline Huang, The Ethox Centre, University of Oxford
On November 22, in a harshly worded “warning letter,” the US Food and Drug Administration (FDA) informed the direct-to-consumer genetic testing (DTC-GT) company 23andMe that it had 15 working days to discontinue marketing of its services. By December 5, 23andMe had canceled television, radio, and online advertising and stopped selling its $99 ‘spit kit’ DNA test online.
To put it mildly, the FDA and 23andMe have some communication issues to resolve. A working relationship dating back to 2008 appears to have soured after a six-month period of silence from 23andMe, prompting the warning letter and causing many observers to comment on the apparent stupidity and mystifying nature of 23andMe’s communication ”strategy.” While the FDA’s letter is quite clear that 23andMe must communicate better, particularly in reporting the accuracy of its tests, it is not at all clear on how the FDA plans to regulate companies like 23andMe after these accuracy results are in. Moreover, it hints strongly that some tests may be banned even if they are as accurate as the tests you could receive through a physician.
Assuming 23andMe follows through on its promise to cooperate with the FDA, how exactly should these DTC-GT services be regulated to best serve the public?
It was announced last week that a new offence of ‘wilful neglect or mistreatment’ is to be created for NHS hospital staff whose conduct amounts to the deliberate or reckless mistreatment of patients. This offence will be modeled on an existing offence under the Mental Capacity Act which punishes the wilful neglect or ill-treatment of patients lacking capacity. Currently, a medical worker convicted of this offence faces a maximum sentence of five years imprisonment, or an unlimited fine. The sanctions for the proposed new offence are likely to be of a similar severity.
The creation of the offence comes in the wake of the inquiry into the widespread negligence that occurred at Mid Staffordshire hospital. Intended principally to deter healthcare workers from mistreating patients, the new offence has been proposed following review of patient safety. The leader of the review, Professor Don Berwick, emphasized that patient safety must become the top priority and that the measure was needed to target the worst cases of a ‘couldn’t care less’ attitude that led to ‘wilful or reckless neglect or mistreatment’.
Concerns about its impact
Whilst most would agree that patient safety should clearly be a priority, there has been concern that the new criminal sanction could create a ‘climate of fear’ amongst healthcare workers and that individual workers will be penalised for mistakes that are the result of inadequate staffing or simple human error, rather than blameworthy acts of malice. Continue reading
The furore over Syria at the G20 meeting has distracted attention from the potentially highly significant agreement by the leaders of the world’s largest economies to support an ‘ambitious and comprehensive’ plan to address the massive global problem of multinational corporations’ failure to pay tax where they earn it, using transfer pricing and other methods to pay lower tax elsewhere or none at all. Continue reading
Andrew Culliford, whose story is featured in the Daily Mail, is one of the estimated 7 in 100,000 people living with Motor Neuron disease, a progressive degenerative disease which attacks muscles, leaving those affected eventually unable even to breathe unassisted. For Andrew, a young father who has a severe form of the disease, it means a two to five year life expectancy.
The US introduced a mandatory pre-approval process for pharmaceutical drugs after over 100 people were killed by an untested drug formulation . Today, each drug must go through a series of strictly controlled trials, including Phase 1 tests on healthy volunteers, followed by Phases 2 and 3 which test the drug and dosages on smaller and then larger patient groups. The process is estimated to cost $500 million per drug and to take 8 – 12 years.
The process is designed to ensure the efficacy of drugs has been scientifically demonstrated to a very degree of confidence, and to ensure that patient safety is sufficiently protected. In many ways it has been a triumph of science and regulation.
But it has been a failure for one small group of patients: those with rare, imminently lethal diseases, for whom there are no existing good treatments. Those who will die in less than 8 years. It is these patients who are asking to have access to untested medicines, and to avoid placebo controlled trials, where half the participants are given no drug at all. Les has proposed innovative methods of patient recording data. I have discussed this proposal previously on this blog , and in a joint paper with Les Halpin and clinicians.