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Patient groups and NICE

24-Aug-10

When writing a scientific paper, one task during the process of submitting the paper is to gather up the conflicts of interest so that readers can judge if they may have introduced bias into your paper. They may not have, but all the same it is the general view that providing such information is important. Here is an example from a paper by Rob Glynne-Jones, “Anal Cancer: The End of the Road for Neoadjuvant Chemoradiotherapy?”

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a “U” are those for which no compensation was received; those relationships marked with a “C” were compensated. For a detailed description of the disclosure categories, or for more information about ASCO’s conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Employment or Leadership Position: None Consultant or Advisory Role: Rob Glynne-Jones, Roche (C), Sanofi-aventis (C), Merck Serono (C) Stock Ownership: None Honoraria: Rob Glynne-Jones, Roche, Sanofi-aventis, Merck Serono Research Funding: Rob Glynne-Jones, Roche Expert Testimony: None Other Remuneration: None

It is therefore interesting to note that Rob Glynne-Jones is in the Daily Mail, in his capacity as chief medical advisor to a patient group, talking about a recent NICE decision relating to Avastin (bevacizumab) manufactured by Roche:

Rob Glynne Jones, chief medical adviser at Bowel Cancer UK, said: ‘I know that NICE has to be rigorous in its appraisal of treatments and that it looks in detail at individual drug trials to assess cost-effectiveness.

‘However, as a practising oncologist, if we simply look at survival in the UK, I can see that in even the most up-to-date national drug trials patients with advanced bowel cancer have an average 19 months survival. This compares to up to 27 months survival for patients in countries that use Bevacizumab (Avastin), such as in mainland Europe and the United States.

‘I can’t argue with NICE’s decision, but I am disappointed. These statistics tell their own story and imply that we are likely to fall even further behind in world-wide league tables.’

The Daily Mail piece (and the same goes for other news sources) does not make the effort to investigate or report any conflicts of interests. Given the relative influence of a journal article versus the Daily Mail, it is arguable that the conflicts of interest statement would be far more useful in the newspaper than the journal. Of course, it is a fallacy to suggest that such funding automatically undermines any argument put forward by Glynne-Jones. His argument, and assessment of the evidence, could be correct. However, in the quote above he draws attention to an alleged 8 month gap in survival for advanced bowel cancer between the UK and other countries that do use bevacizumab. There may well be such a difference, but that could be caused by a multitude of other factors. He states that he cannot argue with NICE’s decision. NICE have suggested an increased survival of 6 weeks with bevacizumab, that’s 26 weeks shorter than the benefit Glynne-Jones appears to infer in his statement.

As already mentioned, Glynn-Jones is the chief medical advisor to Bowel Cancer UK. That is one of two charities mentioned in the news today taking issue with the NICE decision on bevacizumab, the other charity is Beating Bowel Cancer. Even a quick look at their websites revealed links to the manufacturers of the bevacizumab in the past. Bowel Cancer UK received “an unrestricted educational grant from Roche Products Ltd” and Beating Bowel Cancer received “an educational grant” from Roche. Whether there is an ongoing relationship is not immediately clear.

Ferner and McDowell noted in a superb piece on how to outflank NICE, that:

Patients may wish to have treatments that NICE has yet to pronounce on or has recommended against. Patient groups share a common interest with drug companies in promoting access to specific treatments that others will pay for, and so they provide a route for companies to influence the perceptions of their drugs at a distance. As Jo Spink, a public relations professional, explains, “Patients are a powerful force and can highlight the clinical, societal and quality of life benefits of a treatment far more passionately than any press release ever could.”

Patient groups have been described as conduits for drug companies to promote their products and as “ground troops” to be used to lobby governments for increased access to new drugs. A recent survey found that 76% of patient groups based in the European Union received support from drug companies, although how much they received was unclear.w14 Groups campaigning for NICE to approve specific drugs often have declared corporate relations with pharmaceutical companies. Financial support from a drug company may not compromise a patient group’s independence, but companies are not motivated by altruism, and the House of Commons Health Select Committee has advised that measures be taken to limit the influence of industry on patient groups.

Four years later, people are still having to call for transparency on the funding of Patient Groups within the EU.

Filed in EBM, The Industry | | Comments (2) »

The Coalition NHS White Paper

13-Jul-10

This isn’t a post in which I am going to set out my views on the NHS White Paper issued today, I’ve only skimmed it. I am going to note in passing that some people have failed to pay attention to what the coalition parties, with a particular focus on the Liberal Democrats, were saying before the election.

In addition, the White Paper is radical enough, without having to invent things that are not going to happen. There’s going to be a lot of that, just as there were continual erroneous mutterings about creeping privatisation under Labour – which knee-capped Labour’s ability to reform the NHS.

Here’s an example of the latter from the Liberal Conspiracy website: The coalition’s plan now is to dismantle the NHS. The article sets out the Conservative-Liberal plans as the death of the NHS. I’m not going to rebutt all the article, since I have some concerns about the White paper myself, but will show you one example.

The Liberal Conspiracy article suggests NICE in under threat:

The next step might be the eradication of NICE, a health economics body that is unparalleled anywhere in the world despite the covetous eyes which health ministers direct towards it.

Let’s see what the White Paper says about NICE:

Progress on outcomes will be supported by quality standards. These will be developed for the NHS Commissioning Board by NICE, who will develop authoritative standards setting out each part of the patient pathway, and indicators for each step. NICE will rapidly expand its existing work programme to create a comprehensive library of standards for all the main pathways of care.
[...]
We will expand the role of NICE to develop quality standards for social care. The Health Bill will put NICE on a firmer statutory footing, securing its independence and core functions and extending its remit to social care.

So NICE would appear safe after all. Indeed, NICE would appear to be a crucial part of the government’s plans.

The end of the article states:

Remind me, how many Lib Dem voters voted for this: the eradication of the most progressive institution of the 20th Century?

Well, let’s see. Here’s Norman Lamb’s (Lib Dem health spokesman at the time) thoughts from February:

Health quangos and primary care trusts should be abolished, according to Liberal Democrat health spokesman Norman Lamb’s personal proposals.

His The NHS: a liberal blueprint, published by think tank CentreForum, suggests replacing PCTs with elected local health boards with the power to raise cash and source healthcare from NHS, private or voluntary providers.

It says giving local boards financial and political responsibility would cut central bureaucracy and encourage them to improve efficiency, enforced by a corresponding “payments by results” system.

And in April of this year:

With the polls tipping in their favour, the Lib Dems are under increasing pressure to spell out what they would do in the case of a hung parliament, or if they were to win outright. The shadow health spokesman says axing SHAs, devolving power to local bodies and focusing on prevention would be among his first moves

If you read the whole of that article , you can read it as a prototype of the White Paper:

  • Movement of control to local areas
  • Move to trusting clinicians “We will trust clinicians to know what is best for their patients”
  • Concern about micromanagement and desire to cut back on central government
  • Clear indications that SHAs will be abolished
  • Reduction in health quangos
  • Better integration between health and social care

The White Paper is not a Conservative agenda forced on a supine Liberal Democrat poodle. It is document that strongly reflects Liberal Democrat positions before the election. Whether that is a good or bad thing I leave to Liberal Democrat voters to decide. I was not one of them, although interestingly Liberal Conspiracy endorsed the Liberal Democrats. They cannot say they have been tricked or misled though.

It was all there before the election.

Filed in NHS, Politics | | Comments (0) »

Friday links

28-May-10

Wakefield lessons: Economist, Spiked on-line [plenty to take issue with there], and Evan Harris with the real questions that need addressing in the BMJ. | Orlistat weight-loss drug and liver disease FDA. | Simvastatin 80mg, the evidence NPC. | Mixed results on decriminalising dispensing errors PJ | Advanced Short Course in Pharmacoepidemiology at the LSHTM on 26 – 28 July 2010, some great speakers including Mike Rawlins from NICE.

Have a great weekend!

Filed in Friday links | | Comments (3) »

Please sponsor me!

27-May-10

I have taken the breathtakingly stupid decision to run the Berlin Marathon on September 26th 2010. I have done a couple of half marathons, and usually I’m too inhibited to request donations for charity.

However, given that this may well be my one and only marathon, I thought I would try and raise some money for a Hospice who provide care to terminally ill people both at home and in their institution. The hospice is St Giles Hospice. They provide a valuable service, and are independent of the NHS. They depend on charitable donations.

So, please consider donating money via my Just Giving page, and I promise to run as fast as I am able!

UK donations can also be sent by cheque made payable to “St Giles Hospice”. The address is:

Anthony Cox
Aston Pharmacy School
Aston University
Birmingham
B4 7ET

Filed in Personal, Run Fatboy Run! | | Comments (1) »

Wakefield: One less crocodile in the swamp

25-May-10

I’ve been blogging on the MMR vaccine controversy here since 2003, writing letters to my professional journal about the safety of the vaccine since 2002, and prior to that arguing with kooks on the internet in internet newsgroups about vaccines. While over that time the claims supporting any link between MMR vaccine and autism were weak to non-existent, the science base that undermined the hypothesis Wakefield put forward has grown in size, including the epidemiological data and the virological data. So, that’s the science. The decision to strike off Wakefield adds nothing to this assessment, which could have been made years ago.

Although the science is clear, Wakefield’s reputation may well be important. Wakefield is a great communicator. He comes across well on the media. He is confident, and his mix of righteous concern about children, and persecution complex about the government, probably play well to a certain section of society. For that reason, his striking off from the GMC register for professional misconduct in relation to his research is important; he will become damaged goods. You don’t see many newspapers going to David Irving on matters of historical accuracy, since David Irving v Penguin Books and Deborah Lipstadt. It’s worth remembering that there have been accusations that Wakefield changed and manipulated his data, and was aware of negative reports in his work. He has also misrepresented epidemiological data about autism. The public though still see the case, as presented to them by the media, as competing scientific theories. Now, it may be the case that for the cult of Saint Wakefield, his striking off will give him a boost. His book, sickeningly playing on the words used by the GMC, Callous Disregard has even been been timed to make best use of the publicity. However, when it comes to the public, only the striking off may give the emphatic coda to this dismal tale that is needed.

Like a man caught in an avalanche, he has a brief period of time as the snow settles to try and claw his way to the surface. But that’s it. Apart from lecture tours in the US, where the anti-vaccine movement is proportionately bigger and hence able to sustain cranks, he is finished.

I used to think Wakefield was a man with genuine concerns, who painted himself into a corner and was unable to find a way out. As he continued to uphold his views in the face of increasing evidence undermining his hypothesis, and reports about his conflicts of interest and the scientific conduct of his work grew, I became more convinced that he was the major problem, and that the view that the media was mainly to blame was simplistic. It is undoubtedly the case that the media are poor at science reporting, and will often interpret sober science as scare stories. Most scientists find this dismaying and will attempt to correct it, but not Wakefield. He has been ever-present throughout this fiasco pushing his theory.

However, while Wakefield has gone, the media environment that allowed him to drive down vaccination rates continues to exist, and despite some notable individuals (The amazing Brian Deer, who has been targeted by the UK anti-vaccine movement for his pains) there has been little reflection on their role in the affair. Tom Chivers at The Telegraph is an exception today. In 2003 I blogged the results of a study into the media presentation of the MMR vaccine debate:

People have been misled by media reports that the measles, mumps and rubella vaccine could be unsafe, according to new research. A survey by Cardiff University claims that more than half of the British public wrongly believe that medical science opinion was split down the middle on the subject.

But in fact almost all scientific experts rejected the claim of a link between the measles, mumps and rubella (MMR) vaccine and autism, said the research.

This morning, Today gave Andrew Wakefield an easy ride. Compared to the grilling politicians get, he had it easy. They have form. Last year, they allowed him on to accuse Simon Murch, a former colleague of his who was not struck off today, of being silenced by unseen forces. Even anti-establishment magazines, like Private Eye, bought into the conspiracy. The health editor of The Independent reports on Wakefield’s striking off, but fails to mention the role of the media. Most of the media is unrepentant, or has moved on and forgotten their role in the affair. So now Wakefield has gone, we are left with the same media swamp that allowed him to rampage on their pages.

There is some hope that the MMR vaccine scare has had a limited effect on the public perception of other vaccines, but swamps remain the favourite haunts of crocodiles.

Filed in Autism, MMR, Media | | Comments (3) »

Brum Skeptics Blog

14-May-10

Birmingham Skeptics have launched a new blog, with a post from Jack of Kent noting Birmingham’s tradition of free thought:

Birmingham was always more of market town than an industrial town, though it was one where small businesses could easily set up. Before the Cadburys there was really little large scale factory production. And matched with this commercial freedom was intellectual freedom. The local Anglican church was weak. The town attracted freethinkers and non-conformists. Most notably, it was the home of the Lunar Society, a group of the pre-eminent intellectuals of the day. They met once a month, and were known to some as the Lunatics.

Now there are the Birmingham Skeptics. They too meet once a month, like the Lunar Society; and they also meet in a pub, like those sensible mid-Victorian councillors. So in these ways, at least, they are fully within the liberal and libertine traditions of Britain’s greatest city.

Filed in Internet, Quackery, Skepticism | | Comments (0) »

Wakefield in his own words

06-Apr-10

Here is a video made by Brian Deer, which transposes his explanation of Wakefield’s behaviour with words from a recent interview with Wakefield.

Hat-tip: LBRB.

Filed in Autism, MMR | | Comments (2) »

Homeopathic Society complain about methods

22-Feb-10

Chief Executive of the British Homeopathic Society, Cristal Sumner, states with regard to the Parliamentary Science committee’s devastating report on homeopathy:

‘It does seem an irresponsible way of decision-making for a Committee of four voting members to draw conclusions that impact the health and welfare of thousands of patients from just four and half hours of verbal testimony on three distinct topics and from a number of written submissions that were each limited to just 3000 words.’

She went on to suggest only a meta-analysis would be a valid method of assessing whether homeopathy impacted on the health of patients.

Only kidding. She didn’t.

Filed in Quackery, Science | | Comments (5) »

Homeopathy and Pharmacy

22-Feb-10

The House of Commons select committee on science and technology has been examining homeopathy, and their report has been just been released. The main focus will be on the committee’s view that both NHS funding and MHRA licencing should be withdrawn. I’ll focus on the parts related more directly to Pharmacy and the Royal Pharmaceutical Society of Great Britain (RPSGB). First the good:

  • The RPSGB is described as being firmly in the “critic” camp against homeopathy, arguing that “no plausible scientific reason has yet been proposed as to why it should work”. (Page 14)
  • The RPSGB is cited in the decision to correctly inform patients about homeopathy: “It is essential [...] that the patient is given the appropriate information to make these informed choices and as a consequence it should be clear to the patient that there is no scientific evidence for homeopathy.” (page 26)
  • The RPSGB concerns about the homeopathy literature’s weaknesses and how this literature is used to assess homeopathic preparations by the MHRA are noted. (page 33)
  • The RPSGB expressed concerns over the legitimisation of homeopathy caused by sale of homeopathy in pharmacies and MHRA licensing scheme. (page 39)

and the bad:

  • Criticism of the RPSGB suggestion on advice for patient. RPSGB suggest telling patient there is no evidence; committee argue that the only advice that can be given is the product is a placebo. (page 39).
  • Enforcement activities. The strongest criticism of the RPSGB comes in a criticism of their regulatory role. Investigations of homeopathic pharmacies selling anti-malaria homeopathic remedies still not concluded 4 years after raised (page 41).

The RPSGB do come across as a slightly confused organisation, who have struggled through the the past few months to re-align their views on homeopathy. The evidence to the committee was seemingly at odds with the material on their website. Thankfully, the scientific view appears to have won out, and it is expected that new guidance to pharmacists will be science-based.

There are two recommendations at the end of the report relating to pharmacy.

30. We consider that the way to deal with the sale of homeopathic products is to remove any medical claim and any implied endorsement of efficacy by the MHRA—other than where its evidential standards used to assess conventional medicines have been met—and for the labelling to make it explicit that there is no scientific evidence that homeopathic products work beyond the placebo effect. (Paragraph 146)

31. Although it goes wider than the scope of this Evidence Check inquiry we must put on record our concern about the length of time the RPSGB appears to be taking to investigate and reach conclusions on cases where it has been alleged that its guidelines on the sale of homeopathic products have been breached. We recommend that the Government enquires into whether the RPSGB, and from the 2010 handover, the General Pharmaceutical Council, is doing an adequate job in respect of the time taken to pursue complaints. (Paragraph 151)

The committee stops short of suggesting homeopathy should not be sold by pharmacies, instead preferring that they are sold honestly. The central problem with homeopathy is the legitimacy given to it by NHS funding and government regulation. Tackling that will improve the position pharmacists are put in.

However, there is still plenty of work to be done in pharmacy. How can it be that there is a registered pharmacy regulated by the Royal Pharmaceutical Society supplying Leptospira, leprosy, and hepatitis remedies openly over the internet? It’s hard to reconcile that pharmacy’s continued registration with the Society’s position on homeopathy.

Filed in Professional regulation, Quackery, Regulators, pharmacists | | Comments (5) »