Sunday, September 13, 2009

Old & Young: E. Coli O157

Looks like E. Coli O157:H7 is causing mayhem again, affecting mainly children that visited a farm.


September 13, 2009

Godstone Farm/Gareth Fuller
"Thousands of children across the South of England may be at risk from the E. Coli 
bug in what looks to be the largest UK outbreak linked to transmission from farm animals.


"Godstone Farm in Surrey, a popular family attraction where children are encouraged to stroke and touch animals, is closed while the Health Protection Agency (HPA) conducts tests to find out the cause of the outbreak which has left 12 children in hospital, four of them in a serious condition.

"Thirty-six cases, including some adults, have been reported by GPs.
"About 1,000 children, mainly from South London, Surrey, Kent and Sussex, visit the farm every day during the school holidays and at weekends. It is feared that 30,000 children could be at risk of infection."

Remember Scotland 1996?
One of the first major E. Coli O157:H7 outbreak that affected mainly old people in the United Kingdom.
From the BMJ 1996;313:1424 (7 December)
E Coli O157 kills five people in Scotland
"An inquiry had been set up to examine the circumstances behind Britain's worst outbreak of food poisoning from Escherichia coli 0157, which has resulted in five deaths and left 280 people ill.
"The outbreak, in central Scotland, has been linked to cold and cooked meat products sold by a butcher, John Barr and Son, in the Lanarkshire town of Wishawand supplied to dozens of outlets in the surrounding area.

"The deaths have all occurred among elderly people, two of whom were among a group of pensioners who shared a meal at a church in Wishaw on 17 November. They had eaten a steak pie supplied by John Barr, and tests have since confirmed the presence of E coli bacteria in the gravy. It soon became clear, however, that the problem was not confined to Wishaw when people from a wider area began reporting symptoms."

E.Coli O157:H7 can be very virulent and it is believed that as little as 5 individual germs can cause serious damage especially by causing kidney failure. We have little understanding still of how bacteria act but it is now known that E. Coli O157: H7 uses Quorum Sensing. The condition at the farm must have been ideal for them.

We also need to understand about the proliferation of bacteria such as E. Coli and MRSA and C. difficile in our farm animals.

According to The Union of Concerned Scientists:
Microbial Drug Resistance 13(1):69-76.Akwar et al. 2007.
Risk factors for antimicrobial resistance among fecal Escherichia coli from residents on forty-three swine farms.
"Akwar et al. found that people living and working on swine farms where antibiotics were used in feed had increased chances of carrying resistant E. coli. In some cases, the risk of resistance for the farm workers was higher than if they had taken antibiotics themselves. Once farm workers are colonized by resistant bacteria they can transfer them to family members and others in their community."

The use of antibiotics in farm animals is widespread and is not restricted to the treatment of infections but for the enhancment of weight gain. In business terms it is the conversion ratio of feed to weight that matters. The Obama government may well be taking steps to control it due to the rising incidents of Hospital Infections. (See MRSA & Antibiotics: Obama & Farmers.) Chicken and other animals can grow up to twice as fast as 30 years ago when antibiotics were not in the feeds. Scary!
It may therefore require more than "washing hands" if we do not want more outbreaks like this and other ones.

Latest: Twins

1996 Report: Pennington Report

Thursday, September 10, 2009

NHS & McKinsey: The Professor & 10%

Professor Allyson Pollock is at it again and this time in The Guardian:


Professor Allyson Pollock

The NHS is about care, not markets
The Guardian Thursday 3 September 2009
Downsizing the workforce is a business response to loss of profit – but it doesn't account for the NHS goal of universal healthcare.
I will attempt to look at Professor Pollock’s article in detail especially as we come up to the anniversary of the failure of Lehman Brothers.

Healthcare in the market place:
The core goal of universal healthcare and services planned on the basis of need and not ability to pay is being jettisoned by the turnaround teams and management teams brought in to manage anticipated reductions in NHS budgets. Downsizing the workforce is a traditional response of business to loss of profit where businesses have to pay the costs of operating in a market and earn surpluses for shareholders. Unlike Scotland and Wales, the NHS in England is continuing to pursue market-oriented healthcare in its reform of the NHS. So it should be no surprise that management consultants firm McKinsey have come up with market-oriented solutions to anticipated budgetary shorfalls. They have advised ministers to cut 10% of the NHS workforce in England by 2014, a reduction that will affect services provided primarily to the old and the poor who have among the highest healthcare needs. But strategies to reduce the NHS budget need to pay attention to the role of market structures and how they reduce the ability of the NHS to pool the risks and costs of care across its population.

Administration costs:
The diversion of health spending from patient care to paying for a market are not apparently McKinsey's concern. Take for example the costs of the new market bureaucracy; for more than 40 years administration costs were in the order of 6% of the total budget a year, they doubled overnight to 12% in 1991 with the introduction of the internal market. We have no data today for England, but what we know from the US is that the introduction of for-profit providers increases administrative costs to the order of 30% or more.

Different to Scotland and Wales:
So why hasn't McKinsey advocated making savings along the lines of Scotland and Wales by reintegrating trusts into area-based planning structures and thereby abolishing billing, invoicing, the enormous finance departments, marketing budgets and management consultants, lawyers, commercial contracts? In this way one could project savings of anything from £6-24bn a year for England.

PFI:
A second set of savings would be the high costs of PFI where the taxpayer, having bailed out the banks, is now paying almost twice as much as it should for some PFI hospitals through high rates of interest and returns to shareholders. The total money raised from private finance so far is £12.27bn but the NHS will pay out £41.4bn for the availability of buildings and a total of £70bn over the life of the contracts. The irony is that the patient and the public are rebuilding the banks' balance sheets using scarce NHS funds intended for patient care and staff, especially in community-based services.

ISTC:
A third saving could be made by cancelling the contracts for the £5bn ISTCs programme – research in Scotland extrapolated to England has shown as much as £1bn has been wasted by giving money to for-profit ISTCs for work that was not carried out in the first wave.
Then there are all the other contracted out services including the pharmaceutical bill of £14bn. Are these contracted out elements part of the McKinsey scrutiny? It is doubtful since the company travels the world advocating market solutions.

Failures:
And here we run up against the fundamental problem of retaining marketeers to advise on healthcare. Markets mean reducing the capacity of the NHS to pool the costs of care across the whole service, substituting instead hospitals, clinics and practices that have to pay their way like businesses and, like businesses, can fail. Needs-based planning, once the hallmark of the NHS in England, is being replaced by strategies to deal with artificially created market failure.
Solutions are sought from outside consultants and turnaround teams using unsubstantiated assertions that the NHS is inefficient and can increase productivity. What the selective use of data and evidence mask is the failure to view the system as a whole and to remember that its core goal is universal healthcare, not concocted operating surpluses.

Winners and losers should not be what universal healthcare is about:
In contrast to Wales and Scotland, England has established hospitals and services as competing trusts or firms operating in a market; competition has replaced the mechanisms which enabled health authorities to monitor and respond and direct resources to the needs of the populations that are being served. But markets create winners and losers – and the unpublished McKinsey report is an attempt at refereeing.

The moral is that if the Department of Health in England commissions private management consultants that derive their profits from markets you will get market solutions. It is the commissioning, not McKinsey's report itself, that should give offence.


From the Book by Allyson Pollock: NHS plc
The NHS is being dismantled and privatised. Very soon every part of it will have been ‘unbundled' and commodified...a new business dynamic is taking charge of the ways in which services are provided and patients are responded to. The dramatic costs involved - in terms of loss of equal access and universal standards, as well as of money - are concealed by claims of ‘commercial confidentiality' and by tearing up the once-exemplary systems of NHS accounting

I just hope the Professor will not be one of the 10%.

Grand Rounds: Vol. 5 No. 52 Suture for a Living

What is wrong with the market approach:






Others:

NHS & the Repeal Of The Glass-Steagall Act


To Intervene Or Not: A Colossal Failure Of Common Sense.


NHS: Business Model? Spare Us Please!!!



Article: The Guardian

Thursday, September 3, 2009

Pfizer, Geodon (Ziprasidone ) & The Twist


In the New York Times:

“The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.”


“The government charged that executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain. While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales.”


My main interest is in the antipsychotic Geodon (Ziprasidone )

  

From Reuters:

“Geodon is FDA-approved only to treat patients ages 18-65 diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder. However, according to the whistleblower suit unsealed today, Pfizer illegally promoted the sale and use of Geodon for a variety of off-label conditions,

including depression, bipolar maintenance, mood disorder, anxiety, aggression, dementia, attention deficit hyperactivity disorder, obsessive compulsive disorder, autism, posttraumatic stress disorder, and for pediatric, adolescent and geriatric patients.”

That sounds like every known condition!!!

"Pfizer targeted pediatrics and adolescents to expand off-label use and maintained on its payroll an army of more than 250 child psychiatrists nationwide." Kenney stated that, "Pfizer regularly paid generous speaking fees to these child psychiatrists to give what were basically promotional lectures about the benefits of Geodon to their peers, who were naturally also child psychiatrists, despite the fact the drug is not FDA-approved or medically indicated to treat children at all."


"……the purpose and intent of paying so many child psychiatrists is clear-- to gain a foothold within the fastest growing market for antipsychotics --children. The practice of expansive off-label use is dangerous, particularly in children because the drug has not been evaluated for its safety for the unique physiological make up of children."


"……less than 5% of the United States population is diagnosed with schizophrenia or bipolar disorder, yet in 2008 Geodon surpassed the blockbuster benchmark of $1 billion in sales."


"……after drug makers obtain initial FDA approval for a specific use, they often don't bother with expensive testing that would allow them to request a label extension for other uses. They just market the drug off-label."


Danger:

"……among Geodon's most dangerous side effects is its potential to affect the heart's rhythm, a condition known as QT prolongation, which increases the risk of sudden cardiac death."


Antibiotic as well?

As part of the overall settlement, Pfizer agreed to pay $100 million to resolve allegations that it engaged in the marketing of Zyvox for a variety of off-label conditions beyond the methicillin-resistent Staphylococcus aureus ("MRSA") infections for which Zyvox was FDA-approved.


Is anything sacred anymore?
 

The twist: this is better than a John Grisham Novel

Associated Press:

“Authorities called Pfizer a repeat offender, noting it is the company's fourth such settlement of government charges in the last decade. The allegations surround the marketing of 13 different drugs, including big sellers such as Viagra, Zoloft, and Lipitor.”

I was wondering why they could be so blatant:

“In an unusual twist, the head of the Justice Department, Attorney General Eric Holder, did not participate in the record settlement, because he had represented Pfizer on these issues while in private practice.”

What other corporations did he represent?

“Eric Holder, has a net worth of $5.7 million and lobbied on behalf of three companies in the past five years, according to a questionnaire filed by Holder with the Senate Judiciary Committee.

“In the year before Obama appointed him Attorney General, he made more than $2.1 million as a partner at Covington & Burling, a prominent Washington law firm. The money is unsurprising given his high-profile client list, which includes companies like UBS Financial Services, Merck & Co., and Hewlett-Packard. He was also paid to sit on the boards of MCI and Eastman Kodak Company.”


Grande Rounds: Voume5, No 51 at Medic999

Links: Eric Holder,Pfizer Whistleblower, Associated Press, Reuters.

Related Posts
Abilify/aripiprazole: Akathisia-gate
Alaska Zyprexa: DOJ at last.
Alaska, Good Friday Earthquake and Zyprexa
Alaska Zyprexa: Follow Up
Bipolar and ADHD: Boys and Breasts
Antipsychotics: Really?

Wednesday, September 2, 2009

NHS & the Repeal Of The Glass-Steagall Act

Can the minority sometimes be right?
In life, should one maintain a narrow focus and stick to one’s own field, leaving the rest to the so called experts? Or should one have a broader outlook, as one can often learn from the mistakes of others.
Should we be concerned with something that happened in the USA? What was the Glass-Steagall Act anyway?


In 1999 the US Senate voted to pass Gramm-Leach-Bliley
Act by a vote of 90-8.

Photo: Justin Lane, New York Times



Bill Clinton Signs the Gramm-Leach-Bliley Financial Services Act
It reversed what was, for more than six decades, a framework that had governed the functions and reach of the nation's largest banks (Glass-Steagall Act ). As a result, banks are no longer limited by laws and regulations: commercial and investment banks can now merge. Many have already begun the process, including, among others, J.P. Morgan and Citicorp. Banks can now sell insurance and stock. Nearly $300 million was spent to lobby the Senators.
Before 1999, Congress had tried 11 times to repeal Glass-Steagall and failed. Senator Byron Dorgan from North Dakota was one of the dissenters, and Newsweek took up the story:
“North Dakota Sen. Byron Dorgan expressed his fear of ‘exotic new derivatives called swaps way back in 1994. Five years later, when Congress passed legislation lowering the barriers between brokerages and banks, Dorgan told The New York Times, ‘I think we will look back in 10 years' time and say we should not have done this.’ It's been 10 years, and Dorgan was dead-on.”
Bloomberg had more details on Obama’s view:
“Obama himself has decried the way Glass-Steagall was undone, saying it left a regulatory vacuum that contributed to the current crisis.
“A regulatory structure set up for banks in the 1930s needed to change,” then-candidate Obama said in a March 27, 2008 speech at New York City’s Cooper Union. “But by the time the Glass-Steagall Act was repealed in 1999, the $300 million lobbying effort that drove deregulation was more about facilitating mergers than creating an efficient regulatory framework.”
“Obama referred to a campaign by companies such as Citigroup Inc., Merrill Lynch & Co. and Aetna Inc. in the late 1990s to overturn the law. Its demise allowed banks, insurance companies and securities firms to integrate and compete with one another.”
Citigroup’s Birth
“Citicorp, a commercial bank, and insurance company Travelers Group Inc. announced a merger in 1998 that needed Glass- Steagall’s repeal to become legal. The combined entity became Citigroup.”
That actually happened before the Act was repealed!!!
“As commercial banks sought to compete with investment banks, they took bigger trading risks and created off-balance-sheet financing vehicles to help reduce the capital they needed to hold to protect against loan losses. Investment banks became more aggressive in lending to companies and increased their own borrowing to buy securities or real estate.
And the bottom line:
“Phil Gramm, a Republican senator from Texas who co-authored the Gramm-Leach-Bliley Act that repealed many key provisions of Glass-Steagall, later went to work for UBS AG, the Swiss bank whose foray into investment banking contributed an 88% drop in its shares since June 2007. Robert Rubin, a Clinton administration Treasury secretary who advocated Glass-Steagall’s repeal, went on to work for Citigroup, which lost $27.7 billion in 2008 and has needed $45 billion in government funds to remain solvent.”
The parallel with the current lobbying for the reform of the NHS is not difficult to see. Can we not see the danger? The “who is behind what support group” is not transparent and there are only a few of us who sense the hidden agenda enough to vocalize our concerns. The “big boys” are moving in and the MPs that are the likes of the US Senators Gramm and Rubin are now working for the privatization of the NHS by stealth. Watch out for their tactics!
1 July,2009
“In England's health service creeping privatisation is turning into a full-frontal assault as the government strains every nerve to give health corporations a bigger slice of the action: not only in buildings and maintenance, but diagnostics, elective surgery, GPs' surgeries, district nursing, health visiting and trust commissioning – regardless of the views of staff and patients; the evidence on cost, inefficiency and lack of accountability; and the corrosive impact on the NHS ethos.”
This is scary, very scary.
Ex-NHS: Patricia Hewitt: now with Cinven (Bupa Hospitals)