Sex sells. I suppose this is why the results of a study entitled ”Sildenafil Treatment of Women with Antidepressant Associated Sexual Dysfunction” were reported with great enthusiasm around the world after they were published in the Journal of the American Medical Association (Jama). Yet the study is interesting for a number of reasons.
Rest of column here.
The National Institute for Clinical Excellence is proposing that four drugs licensed for the treatment of renal cancer are not to be funded; they are not, we are told, ‘cost effective’. Charities, doctors groups and patients are reported today as condemning the situation with strong criticism of NICE. However, there are surely other criticisms due. If the pharmaceutical companies manufacturing these drugs wanted to make them ‘cost effective’ then they could reduce the cost until they are.
Prostate cancer screening via use of a PSA (prostatic specific antigen) testing – a biological marker found in blood – is one of the most contentious things around. There is no such contention over seeking diagnosis and treatment for prostate symptoms. It is screening for problems when no symptoms exist that is the issue.
While the logical view may be that ‘catching things early’ is a good thing, the truth is rather different (I am getting deja vu: exactly the same thing applies to breast self-examination). PSA testing is even messier, though, in terms of potential harms. A high PSA result can be a false positive for cancer (instead inflammation or a benignly enlarged prostate can cause high results) or false negative (PSA is not elevated where there is prostate cancer present). Additionally, the surgical treatment for prostate cancer can result in major side effects (impotence and incontinence). The crux is, that for prostate cancers found at screening, there may be no benefit to the man in question in improving mortality, but there still may be harm done in terms of ‘treatment’.
While in the UK prostate cancer screening is not routinely done, in the US there is a culture that says ‘all men must know their own PSA’, despite the lack of evidence for this. However, today the US Preventive Services Task Force has said that “Current evidence is insufficient to assess the balance of benefits and harms of screening for prostate cancer in men younger than age 75 years” and “Do not screen for prostate cancer in men age 75 years or older”. There are trials ongoing which will hopefully give us better information, but in the meantime, the circumspect approach in the UK (where generally more information given about the limitations and potential harms of PSA screening leads to a decrease in the amount of men who end up having it done) looks like it is the right one.
There’s an interesting comment piece by Professor Mary Dixon-Woods in the Lancet Oncology this week. The ‘Research Ethics Committee’ approval, which is required before a clinical trial can begin, has been criticised by some doctors as being too slow, too burdensome, and inconsistent. The concern has been that the process of gaining ethical approval for a study is, amongst other things, so bureaucratic that important questions about treatments are not being asked, because it is too hard to get permission to do so. This comment piece looks at the reasons why Research Ethics Committees decide not to approve trials. The major reason, the authors found, was to do with informed consent. In some cases, the REC was concerned that the trial was couched in overly enthusiastic terms, eg a patient information sheets said ‘we hope that participation in the trial will help you by providing the best available treatment for your cancer’.
This is especially interesting, particularly given the recent coverage of the prostate cancer drug abiraterone (see blog post below.) So far, there is one published clinical trial; a study of just 21 men. How are patients going to feel about entering into a trial where they may not get this (overly hyped) drug?