Saturday, 28 September 2013

Pharm Mafia 2

I thought that modern medicine was supposed to be based on science not superstition.  Sometimes I doubt that, when nurses observe a symptom and jump to a diagnosis without checking the facts.

Pharmaceutical companies fund a lot of research on drugs, either directly or indirectly.  I've written before about their wish to conceal results, use Orwellian methods to cosmetically enhance descriptions thereby minimising the readers' awareness of side effects.

Now 2 American drug companies (AbbVie and InterMune) are trying to ban disclosure of any of their research findings for some widely used drugs, for 'commercial reasons.'  Professor Healy has tackled their non scientific approach to side effects before in this AbbVie post.

We know that serious adverse events are often concealed or withheld from public view, for example in the case of statins, which do not, as widely proclaimed, prevent serious adverse events or heart attacks.  I am grateful to Dr Malcolm Kendrick for the latest on this topic.

Here is a letter from David Healy, Professor of Psychiatry in Bangor, Wales presenting a petition to prevent this action.  If you want medicines that are safe, then please sign the petition:

Sorry for the Mass Posting here but we have just posted a Swedish translation of the RxISK petition calling for Access to Clinical Trial Data.
Some of you will have signed this but even if you have read on because we have a mission for you.
Two years ago, the European Ombudsman ruled that the European Medicines Agency should open up access to Clinical Trial Data for anyone who applied from anywhere in the world.
Six months ago two US pharmaceutical companies AbbVie and InterMune took a legal action against EMA that has closed down access to all trial data for all drugs for all doctors and researchers anywhere in the world…

Some of you may not have heard of AbbVie. Until recently they were Abbott Laboratories, one of the biggest pharmaceutical companies in the world.
They make Humira, a monoclonal antibody used for Rheumatoid Arthritis, Crohn’s Disease, Psoriasis and other conditions. It is the best selling drug in the world today, and projected to be the best selling drug of all time.
This is one of the most important legal actions in Healthcare ever. At a recent meeting in Bruxelles AbbVie made it clear that a main reason to keep clinical trial data confidential was to hide adverse event data, although there may be other issues like a Trade War with China.
You can read about this and see the whole video here
Essentially AbbVie are asking the Courts to grant their Corporation the privacy rights of an individual – a very powerful wealthy individual.
But the key help is this. If this legal action succeeds Adverse Event data will be hidden for ever.
So we’d love you and anyone you know to sign a petition calling on AbbVie to drop their legal action against the EMA’s policy of open access to clinical trial data. The petition is here or in Swedish as above
This petition is as much for anyone who may be prescribed drugs as for those prescribing them – so we are hoping to spread word about it generally.
In addition to signing, we are trying to get every country in the world to sign.
We have 72 of the 187 countries in the world signed up but would love to have all.  If any of you have contacts in any Eastern European, African or South East Asian countries that you could get to sign this it would be really excellent
Thanks, David
David Healy
Professor of Psychiatry, Hergest Unit,
Bangor, Wales LL57 2PW, UK

Tuesday, 24 September 2013

Charitable giving?

In the UK there has been concern about charities.  Some were criticised for hoarding money and not using funds to benefit those they claimed to help.  Charities that raised money to help retired working animals were singled out for particular concern.

Some donors were unwilling to give to charities that used a large proportion of money raised on 'overheads'.  Years ago the NSPCC launched a series of harrowing radio and tv ads about child abuse and neglect.  I mentioned this to an NSPCC staff member, who told me that the latest annual report had glossy photos of the brand new headquarters building, implying that the money was raised to cover the construction costs.

Headlines have alerted us to fake charities, started by unscrupulous operators cashing in on tragedies and siphoning off money that donors intend to help people affected by disasters.

A more recent development looks good on the surface.  This involves wealthy companies and/or families setting up charities that benefit the organisation (by tax avoidance) or the family.  Unfortunately they seem to be legal and abuse a system intended to help those in dire need.

The latest twist in this tale involves the NHS.  A patent lawyer was approached about an effective cancer treatment that cost relatively little money to produce.  The patent holder charged over $1 million, so that it was unavailable on the NHS.  The lawyer interviewed half the 200 consultants specialising in this type of cancer.  Some declined to comment.  Others agreed with the clinical assessment of the benefits of the treatment.  However only one of them was willing to testify to this effect.


The others were dependent on pharmaceutical company funding in some way (research, clinical posts etc).  The sole witness, who helped win the case, was recently employed by a UK charity.

Today that case would not be possible.


Because the charity is now mainly funded by a pharmaceutical company.

Dr Peter Gøtzsche speaks about this in his new book on corruption in medicine by the pharmaceutical industry.  The relevant section appears from 6.38 in this video.  (Blogger & Youtube won't let me post this as a video window, so here's the link instead.)

I was aware of some bias in charities when posters to a discussion board were blocked by a UK diabetes charity.  Dr Jay Wortman is a low-carb researcher, who is NOT noted for aggressive behaviour or writing about wildly unsubstantiated ideas.  The moderator characterised Dr Wortman as a troll, which seems absurd for someone dedicated to spreading information that may help people regain health.

I suspect, but cannot prove, that, has some pressure from a major pharma donor to toe the party line and remain on message about medication and high carb, low fat diets.

PS  I am grateful to Lesley Roberts for pointing out my mistake in naming the diabetes charity at the end of this post.  It was and NOT Diabetes UK, which is an entirely different organisation.  Unfortunately the 2 blogs that are linked in this post also conflate the 2 organisations.  Apologies to Diabetes UK for this.

Pharm Mafia 1

Doctor Malcolm Kendrick blogged about the new book by Dr Peter Gøtzsche.

 Dr Gøtzsche heads the Nordic Cochrane Collaboration, an independent, non-profit organisation that organises medical research in a systematic way to provide true evidence based medicine.

Dr Gøtzsche  complained to the European Ombudsman after the EMA (European Medicines Agency) refused access to detailed clinical study reports on 2 anti-obesity drugs.  This led to a reversal by the EMA and a complete overhaul of its policy on access to medical data.

Dr Gøtzsche claims that pharmaceutical companies, who fund and carry out most of the research on licensed drugs, suppress and cosmetically enhance results to give the best spin on the products they sell.  Unfortunately doctors prescribe medicines without reading the original research studies, so tend to believe the hype from drug reps and compromised medical journals.

Dr Peter Gøtzsche states that after heart disease and cancer, prescription drugs are the third biggest killer of people in the USA and Western Europe.  'It's a man made epidemic almost as bad as tobacco'.

He points to the corruption in healthcare and the lack of sufficient control.  'What the drug industry is doing fulfills the RICO criteria for organised crime.'

Tuesday, 17 September 2013

Big Yin brain degeneration isn't funny anymore

Billy Connolly is a Scottish comedian, often called the Big Yin.  He's just been diagnosed with Parkinson's Disease and says he'll continue working for as long as possible.

This is no joke.  I wrote about the impact of carbohydrates (particularly grains) on human health (heart disease and cancer).  Sadly, one of the subjects of my post, Steve Jobs, has since died.

When are we going to learn about carbohydrates, prolonged blood sugar spikes and the damage done by glycation?  How many doctors need to lecture on this before our governments wake up to the dangers?

We hear about drug and gene therapy, as well as genetic predisposition towards dementia and Parkinson's Disease.  No government expert tells us the truth about diet.

Dr William Davis has written about it.  Dr Larry McCleary has focussed on it.  Dr Nanette Yount researches this area.  Others spread the same message, but I haven't noticed much change in our health service provision.

Now Dr David Perlmutter has written a book for a general audience on this subject.

His interview with Jimmy Moore highlights the power of saturated fat in feeding the body and improving brain health and function.  He also talks about the benefit of intermittent fasting to help the body shift into ketosis and make major improvements.

I am pessimistic about Billy Connolly and the likelihood of him adopting a ketogenic diet.  So many 'experts' warn against Ketoacidosis (not the same thing and rare), as well as 'artery clogging' effects of saturated fat (which is not supported by scientific research.)  The fact is that dietary changes don't make a profit for commercial companies.  These major sponsors and 'consultants' to Western governments make sure that drug interventions and surgery take precedence.  All the health service personnel I know will continue to smile at me and use patronising ways of dismissing this work.

My only hope is that ordinary people begin to hear a different message and experiment with changes to their diet.  For me the impact of butter and coconut oil is marked and I enjoy much greater mental clarity when eating them.

Here's one woman who did:

Monday, 16 September 2013

Are Paleo men listening?

I'm a regular listener to Jimmy Moore's low carb podcasts.  He interviews a range of health and nutrition speakers and provides in depth information on the latest research.

Jimmy recently interviewed Sally Fallon from the Weston A Price Foundation.

She is concerned that newcomers to the low carb/paleo field of nutrition may learn about the principles of good nutrition from certain sites that don't give a balanced view and distort what archaeologists have found out about paleo food intake.  

Newcomers might conclude that a paleo diet is low in fat and carb but high in lean meat.  She cites Loren Cordain's first book,  in particular his position on grains, saturated fats, bone broth and organ meats.  The emphasis seems to be more on protein (mostly lean), which doesn't contain all the necessary nutrients, particularly Vitamin A.  Sally Fallon believes that Vitamin A deficiency can lead to severe problems.  Our paleolithic ancestors ate some grains and valued the fatty parts of animals most highly.   'Ancestral' or 'Traditional Diet' helps shift associations away from the low fat, low carb, high lean meat diet towards a more accurate representation of history.

Jimmy Moore later interviewed Loren Cordain, but seemed to turn it into an 'our diet is better than yours' battle.  This was not my understanding of Sally Fallon's position.

Unfortunately Loren Cordain didn't respond to the challenge about his website.  He suggested that Sally Fallon had not spoken to him personally and therefore did not understand his views.  He also dismissed her stance by stating that she is someone with no credentials, but high traction in the marketplace.  He was scathing about her lack of original research.  It's a shame that a pioneer like Cordain can't actually address Sally Fallon's argument and has to resort to personal attacks.  I find it even stranger that he made this point in an interview with Jimmy Moore (no medical/scientific credentials, N=1 research and high traction in the marketplace.)

As far as I can see from the Weston A Price Foundation website, they sell modestly priced pamphlets to help with shopping and preparing food.  Sally Fallon and colleagues have written books, including Wise Traditions Cookbook, but these are not high on the list.  WPF is a membership organisation working towards disseminating the teachings of the founder.

These are the WAPF dietary guidelines:

'1  Eat whole, natural foods.
2  Eat only foods that will spoil, but eat them before they do.
3  Eat naturally-raised meat including fish, seafood, poultry, beef, lamb, game, organ meats & eggs.
4  Eat whole, naturally-produced milk products from pasture-fed cows, preferably raw and/or fermented as whole yogurt, cultured butter, whole cheeses and fresh and sour cream.
5  Use only traditional fats and oils including butter and other animal fats, extra virgin oil, expeller expressed sesame and flax oil and the tropical oils - coconut and palm.
6  Eat fresh fruits & vegetables, preferably organic, in salads & soups, or lightly steamed.
7  Use whole grains & nuts that have been prepared by soaking, sprouting or sour leavening to neutralise phytic acid & other anti-nutrients.
8  Include enzyme-enhanced lacto-fermented vegetables, fruits, beverages & condiments in your diet on a regular basis.
9  Prepare homemade meat stocks from the bones of chicken, beef, lamb or fish & use liberally in soups & sauces.
10  Use herb teas and coffee substitutes in moderation.
11  Use filtered water for cooking and drinking
12  Use unrefined Celtic sea salt & a variety of herbs & spices for food interest & appetite stimulation.
13  Make your own salad dressing using raw vinegar, extra virgin olive oil & expeller expressed flax oil.
14  Use natural sweeteners in moderation, such as raw honey, maple, syrup, dehydrated cane sugar juice and stevia powder.
15  Use only unpaseurised wine or beer in strict moderation with meals.
16  Cook only in stainless steel, cast iron, glass or good quality enamel.
17  Use only natural supplements.
18  Get plenty of sleep, exercise & natural light.
19  Think positive thoughts and minimise stress.
20  Practise forgiveness.'

Cordain does sell books and other merchandise, so there's a commercial aspect to his interviews and website.

His website says:

'What to Eat:

Grass-produced meats, fish/seafood, fresh fruit and veggies, eggs, nuts and seeds, healthful oils (olive, walnut, flaxseed, macadamia, avocado, coconut.)

What not to Eat:

Cereal grains, legumes (including peanuts), dairy, refined sugar, potatoes, processed foods, salt, refined vegetable oils'

Cordain has changed some of his guidelines since the first book was published, but still gives a strong impression of lots of lean meat and mostly monounsaturated fats.

How do people approach a new health and nutrition movement?

I believe that when the prevailing health advice warns people to eat a low fat, high carb diet, then many individuals will be cautious about adopting a high fat, low carb lifestyle.  When people come across the term 'Paleo diet', they are most likely to Google and try to find out what it comprises.  They don't tend to go out and buy a book or get on the phone to the founders.  Many individuals have adopted Paleo, intermittent fasting and other approaches just from reading articles and information on the web.  I regularly read blog posts and discussion board exchanges between people who have done just that.

Here's the Wikipedia version:

'According to certain proponents of the Paleolithic diet, practitioners should derive about 56–65% of their food energy from animal foods and 36–45% from plant foods. They recommend a diet high in protein (19–35% energy) and relatively low in carbohydrates (22–40% energy), with a fat intake (28–58% energy) similar to or higher than that found in Western diets.'

As Sally Fallon points out, searches are most likely to throw up the most popular couple of writers, who advocate a low carb, high lean meat diet.

Loren Cordain argued that he had corrected mistakes in a later book, so her assertion is no longer valid.

How do people buy books?

If they are unsure of the scientific basis of a diet and worried that it might negatively affect their health, they may avoid paying full price for a book on Paleo.  They are less likely to buy from the author's own website.  Amazon market place will throw up lots of modestly priced copies of earlier editions of books.  This means that low fat, low carb messages will be circulating among buyers of the early books of Cordain, Robb Wolf, Dr Terry Wahls and Dr William Davis.  Hey $2.81 for the above book is a bargain right?

It's irrelevant that Loren Cordain and Robb Wolf assert that everything has been corrected in their latest books and that early editions are out of print.  Sometimes new people to the field want to go back to the original books on the subject.  They'll certainly find them on Amazon and eBay.

The most disappointing part of the discussion for me is the role of Jimmy Moore.  He seems to be characterising this as a brand war of diets.  He also colludes with the notion that Sally Fallon is unqualified to speak, even though Jimmy is not and never has been a practising scientist.   In my view Sally Fallon has a better grasp of the modern consumer and health seeking behaviour than most other speakers on the subject.  Her view of how words can be devalued and spread confusion is well made.

Cordain and Wolf assert that they have answered Sally Fallon's claims.  She persists with the notion of the value of saturated fats, not just monounsaturated fats like olive oil.

Has Paleo cleaned up its act?

 One of Jimmy Moore's later interviews was with an enthusiastic supporter of Loren Cordain.  Jimmy Moore favours ketogenic diets and lots of saturated fat, including egg yolks.  Jimmy had no major criticism for Binx Selby, unlike Sally Fallon.  This is the approach of Binx Selby:

'To develop his theories on how a high-fat diet could fight unfavorable cholesterol counts, Selby started by investing two weeks in the library in January to pore over about 3,500 abstracts on the subject. A study from the late 1950s and early 1960s, dubbed the Mediterranean diet for its emphasis on olive oil, informed his thinking most. Ultimately, he designed a diet based on 60 to 70 percent lipids, primarily from olive oil and other plant sources, 20 to 25 percent carbohydrates and 10 to 15 percent proteins.
Then, for two weeks, he played the guinea pig. He drenched everything from kale salads to steamed okra with olive oil and ate only the most low-fat proteins such as fish and egg whites. Every day, he kept his dietary intake within the above percentages and cut out all grains, starchy vegetables and saturated fat — fat originating from an animal sources — to solve his cholesterol problem.'

 Our Paleolithic ancestors might be turning in their graves at how badly they are now misrepresented.

Wednesday, 11 September 2013

The only way is ethics: Co-op Bank and MPs

I find it difficult to respect Members of her Majesty's Parliament.  We've witnessed lying, cheating on expenses claims, accepting money and favours from lobbyists in exchange for influence and many more.

Occasionally I witness serious, principled work by a few MPs on behalf of ordinary people.

Martin Wheatley, Chief Executive of the Financial Conduct Authority, appeared before the HOC Treasury Committee.

Jesse Norman and other MPs raise questions about the Co-op Bank and bondholders.  These run for about 17 minutes 1 hour and 11 minutes into the video.

In other hearings, Norman asks key questions about ethics and the approach of the Co-op Group towards Co-op Bank.  I reproduce some of the exchanges here:

'Q119 Jesse Norman: 
Mr Tucker, why has the Co-operative Group not been asked to make good the losses as the equity shareholder in the Co-operative Bank?
Paul Tucker: I think that is more a question for Andrew as the micro-supervisor.
Andrew Bailey: We have identified the capital shortfall and we have put it to the Co-op that they have to solve this problem, because there is no evidence to suggest that they do not have the resources at their disposal, and I would define that broadly, to do so. They have come up with the approach. The Co-op Group is putting resources into this.
Q121 Jesse Norman: The effect of it is that bondholders will, many of them, be wiped out.
Andrew Bailey: It is a conversion, actually, into equity. Again, you need to ask them this question, really, but it is a combination of resources from the Co-op Group and bondholder conversion, which creates core Tier 1. The key point for us is that they are short on core Tier 1. They have other tranches of capital, instruments, which sit below that, so they have lower Tier 1 capital and they have subordinated debt......
Q123 Jesse Norman: Do you think it is unethical for an institution to walk away from its ownership position?
Andrew Bailey: They are not walking away from it; they are diluting their ownership position quite substantially.
Q124 Chair: But I do not think the bondholders take a bigger hit and it is consonant with the credit hierarchy point that Paul Tucker—
Paul Tucker: But the traditional view of the bank is that owning a bank is a serious thing to do, and as an owner of a bank you should expect to stand behind the bank. Where that is not possible, then resolution beckons as the solution. If you can mimic that through an exchange offer, then that is a better solution still.
Q125 Chair: But do the bondholders not have a right to be a bit aggrieved, bearing in mind that the owners have not taken the first hit that they might otherwise reasonably have expected to do?
Andrew Bailey: I think this is a discussion you must have with the management of the Co-op.
Q126 Chair: Yes, but I am asking your view.
Andrew Bailey: What they have done is, frankly, something that you do see in the non-financial corporate world, which is they have proposed a restructuring. It involves the owner putting in money and the bondholders being converted, and I really do think you have to talk to them about the structure of it.
Q127 Jesse Norman: But one might expect the Co-op, of all institutions, not to obey the Wall Street rule and just walk away from an investment. You would expect them to bear the full responsibility of their ownership.
Andrew Bailey: They obviously have choices to make, and I do think you have to discuss those choices with the management of the Co-op.'
It seems that the Co-op Group believe they run the Bank from behind the scenes, but do not have responsibility for stumping up the money necessary when their decisions and actions go wrong.

Co-op Bank - who shot the sheriff?

The Treasury Select Committee has been taking evidence from people involved in the rapid decline of the Co-op Bank.

Neville Richardson, former CEO of Britannia Building Society and Co-op Bank after the merger, sought to imply that Britannia was in great financial shape before the merger and losses were down to the Co-op and external pressures.  The Bank of England disagrees.  Richardson claims that he was against the Verde project (buying up Lloyds TSB branches) and was forced to resign as a result.  No one has mounted a well argued challenge to Richardson's claims.  In particular, his figures show that losses on the computer side dwarf the losses on the Britannia property portfolio.

In summary ex-Co-op view:  'It was the Co-op Group what done it.'

Niall Booker, CEO of Co-op Bank, appointed on 10 June 2013, wrote a letter to the Treasury Select Committee.  Euan Sutherland, Co-op Group CEO, was appointed to the board of the bank as non-executive director on 9 August 2013.

It appears from the letter that Euan Sutherland approached the PRA to discuss the need for additional capital in early May.  He wasn't on the board of the bank and there is no mention of Barry Tootell or Rod Bulmer, former CEO and replacement CEO of the Co-op Bank at the time.  These discussion took place before the AGM.  It is unclear in what capacity Sutherland was acting.  The Co-op Group have repeatedly said they won't bail out the bank and have an arms length relationship.  Booker's letter implies something different.

A discussion resulted in the decision that no less than £1.5bn in capital resources would be necessary.  A remedial plan was approved by the Bank board by close of business on 14 June 2013 to address the issue.  This is the same day that a formal letter from the Prudential Regulation Authority was received requiring Co-op bank to plug a £1.5bn gap and come up with a plan.  This means the Co-op Bank Board must have met before 14 June 2013 and been made aware of the situation, in order to devise a plan ready for approval on 14 June.

This implies that the Group CEO was speaking on behalf of Co-op Bank in his discussion with the PRA.  Relevant facts were hidden and not raised at an AGM.  Significant Co-op Group funds were authorised to be distributed as a reult of the AGM (and presumably would not have been agreed had the full facts been known.)  There's something fishy about the timing and exactness of the sum needed to fill the funding gap and rescue plan, implying collusion between the Co-op Group Board and the Prudential Regulation Authority (or at least an overly cosy relationship).  The Co-op Group belatedly appoints Sutherland as a non executive director of the Co-op Bank, when it becomes clear that Booker's letter will reveal his shadowy role with the bank.

Booker states that 'No formal correspondence had been received before the letter of 14 June 2013 setting out capital requirements using Basel III definitions.  However as noted above it is not possible to say whether informal discussions had been had with previous management.'

Andrew Bailey, then a senior regulator with the Financial Services Agency, raised concerns about the Co-op Bank from mid 2011.  Unfortunately for Niall Booker, Neville Richardson states that Bailey spoke to the Co-op group twice about financial problems before Len Wardle, Co-op Group chair made a speech about the strength of the Bank's position.

In summary - Co-op view:  'We was poor, but we was honest and did our best with tough outside pressures.'

In summary - senior regulator, investors and legal observers:  'It was the Co-op Group what done it.'

Co-op Bank funding criteria

As reported in previous posts, the Co-op Bank intends to dig itself out of a financial hole by scalping bond and preference shareholders.

It has emerged that the Co-op Bank lends a large sum of money to the Labour Party at very low interest rates.  This is common practice amongst UK banks and political parties.  Perhaps it's tradition or a political move to avoid excess pressure from political parties.

Unfortunately the Labour Party has been in financial difficulties for many years.  The current move by Ed Milliband to demonstrate that trade unions don't have undue influence on policy, by distancing itself from them and ensuring that members don't automatical pay a Labour Party membership fee is increasing the problem.

So the Co-op Bank continues to offer the Labour Party a large unsecured loan, in spite of the precarious finances of Labour.  There are no signs that the bank will call in the loan.  Instead they threaten bond and preference shareholders with a very poor deal, saying that the bank may go into administration if they don't agree.

No surprise then that Ed Milliband made such a fulsome speech on 9 July 2012 at Co-op Bank HQ, focussing on breaking up the BIG banks.

'It is a pleasure to be here at the Co-op.  You have always understood that ethics of responsibility, co-operation and stewardship must be at the heart of what you do.  That's one of the reasons why the Co-op Bank has in the last week seen a 25% rise in applications for accounts.  It was your values that I was talking about last September when I said to the Labour Party conference that Britain needed a different kind of economy....'

He introduced Ed Balls as 'a proud Labour and Co-operative MP'.

Milliband set out a plan to build stewardship banking for Britain to follow the good example of the Co-op Bank.