Tuesday, 16 June 2015

CMO calls for medicines review on safety and efficacy of drugs? To restore public trust?

BBC News have today (16th June 2015) issued the news that the UK government's Chief Medical Officer, Dame Sally Davies, has called for an independent review of the safety and efficacy of medicines as she is worried that recent controversies over the use of medicine "have damaged faith in the way research is carried out and presented".

This must come as a considerable surprise to those people who regularly listen to BBC News.

Just what controversies are these? And what are the problems in the way medical research is carried out and presented? Have we heard about these concerns before?

Apparently, a copy of her request was obtained by the BBC's File on 4 programme as part of an investigation into 'concerns'. So what are these concerns?
  • She is concerned "about the view that doctors and scientists are "untrustworthy".
This has never been said before, certainly not on the BBC, which regularly tells us about new medical breakthroughs, but nothing about any issues with the safety of the drugs patients are given
  • She is concerned about a clot-busting treatment for strokes, a technique called thrombolysis.
What is her concern about this treatment? I have never heard the BBC tell its viewers and listeners anything about this clot-busting treatments. Surely, if there were concerns about thrombolysis, this trusted broadcaster would tell us about it. Wouldn't they?
  • She is concerned about the use of cholesterol-lowing statin drugs for people at low risk of developing heart disease.
What is her concern? The BBC has regularly told us that statins are life-saving drugs, even that they are entirely safe. Certainly, they have never told us otherwise!
  • She is concerned about the use of the anti-viral drug, Tamiflu.
What is her concern? Have the BBC ever told us anything about Tamil, certainly anything that was to do with 'concerns'.

The BBC tells us that the letter reads:

          "There seems to be a view that doctors over-medicate so it is difficult to trust them, and that clinical scientists are all beset by conflicts of interest from industry funding and are therefore untrustworthy too."
  • Doctors over-medicate?
  • Conflicts of interest?
Surely not, surely if these problems existed our trusted BBC, and its health and science correspondents would have told us about it.

The letter also says that none of this is not in the interests of patients or the public's health. Yet it is difficult to believe that the BBC would not have been aware of these threats to patients (who, after all, are the BBC's viewers, listeners and readers), or about threats to public health, without reporting them.

          "I have, therefore, reluctantly come to the conclusion that we do need an authoritative independent report looking at how society should judge the safety and efficacy of drugs as an intervention."

So Dame Sally Davies seems convinced. It does seem that she might be correct. Perhaps in the absence of interest in these matters by the mainstream media, including the BBC, we do need such an 'independent' report.

The BBC articles take up the problem with the treatment of strokes, I believe for the very first time!

          "Each year in the UK, there are more than 150,000 strokes. About 85% are caused by an obstruction blocking the flow of blood to the brain. Patients with this type of stroke may be eligible for treatment with alteplase, subject to tests in hospital. File on 4 visited the hyper-acute stroke unit at Salford Royal NHS Foundation Trust to see how staff assessed and administered alteplase. Dr Jane Molloy, the clinical lead for stroke services, described how they explained the potential benefits to patients and their families. Doctors would say that for every three people treated with this medication one will make some extra improvement, and one in seven will recover their independence who would not do so otherwise, she said.

File on 4 then set out the risks.

          "We know that the risk of bleeding with thrombolysis is six in 100 and that will include minor bleeding but also might include major bleeding with the possibility that it could cause a fatal bleed in the brain."

          "Some doctors say the benefits have been exaggerated. Dr Roger Shinton, a former stroke physician at Birmingham's Heartlands Hospital, is sceptical. He said: 
          "I'm prepared to accept that there are some patients who could get some benefit, but overall it may be that on balance the number of people benefiting is actually quite small and does not justify the use given the significant harms that we know."

His views, as a conventional doctor, are strange indeed. Whenever, and if ever, the BBC investigates medical concerns, it talks to doctors who provide us all with re-assurance. Their strategy is surely foolproof, isn't it? There is a problem with a medical process, so ask those who are committed to that process to give us their opinion.

And yet, read on....

Dr Shinton's concerns have won 'powerful backing' from the former president of the Royal College of Physicians, Sir Richard Thompson, who is quoted as saying:

          "My worry is that the trials are not consistent, that the evidence is not strong enough to be giving, after all, a very expensive treatment. Do we want to recommend a treatment with a marginal effect when we know we are, if you like, killing a few patients and saving others?"

Yes, an important question. I have often heard doctors explain to BBC interviews that the advantages of a drug, or vaccine, or procedure, outweighs the disadvantages. The BBC usually accept this without question. So it is not surprising, perhaps, that in this BBC articles, it finds such an individual, Dr Dale Wenn, from the Stroke Association, who defended the treatment.

          "The evidence says that alteplase has made a big impact on the recovery of stroke survivors. We have to remember that the number of disabilities associated with stroke is greater than any other medical condition. A stroke really can turn your world upside down. What alteplase has done is to improve the long-term recovery outcomes for stroke patients."

And then the BBC finds a statement made by Boeringer Ingelheim, which holds the licence for alteplase in Europe, who said its medicine played a vital role in the treatment of acute strokes.

           "We are confident in our data, which is supported by the experience of clinicians who have been using our medicine to treat their patients for more than a decade. We are incredibly proud of the contribution our medicine makes to patient care at this critical time."

Well, that's the final word, in this BBC article, so perhaps all is well with conventional medical practice. All this investigatory journalism is hard work, questioning people (even medical 'experts'), delving into the outcomes of their practices. Much easier, surely, to listen the what the conventional medical establishment tells us, and go along with it.

And then, Sally Davies does this? I wonder why she wanted to upset the apple-cart? Yes, there are people out here who investigate the outcomes of conventional medical drugs, vaccines and procedures. That's why more and more people are turning to alternative medical therapies.

But shush, that's enough. The BBC might think that it ought to examine these medical therapies with an open mind. It's much easier just to forget about them. And to castigate them, if they are mentioned.

So quiet, all of you. The BBC science and health correspondents are asleep on the job. Don't wake them!