Stem Cell Blindbess Study Results

By ALICIA CHANG, AP Science Writer Alicia Chang, Ap Science Writer   – Wed Jun 23, 7:29 pm ET

LOS ANGELES – Dozens of people who were blinded or otherwise suffered severe eye damage when they were splashed with caustic chemicals had their sight restored with transplants of their own stem cells — a stunning success for the burgeoning cell-therapy field, Italian researchers reported Wednesday.

The treatment worked completely in 82 of 107 eyes and partially in 14 others, with benefits lasting up to a decade so far. One man whose eyes were severely damaged more than 60 years ago now has near-normal vision.

“This is a roaring success,” said ophthalmologist Dr. Ivan Schwab of the University of California, Davis, who had no role in the study — the longest and largest of its kind.

Stem cell transplants offer hope to the thousands of people worldwide every year who suffer chemical burns on their corneas from heavy-duty cleansers or other substances at work or at home.

The approach would not help people with damage to the optic nerve or macular degeneration, which involves the retina. Nor would it work in people who are completely blind in both eyes, because doctors need at least some healthy tissue that they can transplant.

In the study, published online by the New England Journal of Medicine, researchers took a small number of stem cells from a patient’s healthy eye, multiplied them in the lab and placed them into the burned eye, where they were able to grow new corneal tissue to replace what had been damaged. Since the stem cells are from their own bodies, the patients do not need to take anti-rejection drugs.

Adult stem cells have been used for decades to cure blood cancers such as leukemia and diseases like sickle cell anemia. But fixing a problem like damaged eyes is a relatively new use. Researchers have been studying cell therapy for a host of other diseases, including diabetes and heart failure, with limited success.

Adult stem cells, which are found around the body, are different from embryonic stem cells, which come from human embryos and have stirred ethical concerns because removing the cells requires destroying the embryos.

Currently, people with eye burns can get an artificial cornea, a procedure that carries such complications as infection and glaucoma, or they can receive a transplant using stem cells from a cadaver, but that requires taking drugs to prevent rejection.

The Italian study involved 106 patients treated between 1998 and 2007. Most had extensive damage in one eye, and some had such limited vision that they could only sense light, count fingers or perceive hand motions. Many had been blind for years and had had unsuccessful operations to restore their vision.

The cells were taken from the limbus, the rim around the cornea, the clear window that covers the colored part of the eye. In a normal eye, stem cells in the limbus are like factories, churning out new cells to replace dead corneal cells. When an injury kills off the stem cells, scar tissue forms over the cornea, clouding vision and causing blindness.

In the Italian study, the doctors removed scar tissue over the cornea and glued the laboratory-grown stem cells over the injured eye. In cases where both eyes were damaged by burns, cells were taken from an unaffected part of the limbus.

Researchers followed the patients for an average of three years and some as long as a decade. More than three-quarters regained sight after the transplant. An additional 13 percent were considered a partial success. Though their vision improved, they still had some cloudiness in the cornea.

Patients with superficial damage were able to see within one to two months. Those with more extensive injuries took several months longer.

“They were incredibly happy. Some said it was a miracle,” said one of the study leaders, Graziella Pellegrini of the University of Modena’s Center for Regenerative Medicine in Italy. “It was not a miracle. It was simply a technique.”

The study was partly funded by the Italian government.

Researchers in the United States have been testing a different way to use self-supplied stem cells, but that work is preliminary.

One of the successful transplants in the Italian study involved a man who had severe damage in both eyes as a result of a chemical burn in 1948. Doctors grafted stem cells from a small section of his left eye to both eyes. His vision is now close to normal.

In 2008, there were 2,850 work-related chemical burns to the eyes in the United States, according to the Bureau of Labor Statistics.

Schwab of UC Davis said stem cell transplants would not help those blinded by burns in both eyes because doctors need stem cells to do the procedure.

“I don’t want to give the false hope that this will answer their prayers,” he said.

Dr. Sophie Deng, a cornea expert at the UCLA’s Jules Stein Eye Institute, said the biggest advantage was that the Italian doctors were able to expand the number of stem cells in the lab. This technique is less invasive than taking a large tissue sample from the eye and lowers the chance of an eye injury.

“The key is whether you can find a good stem cell population and expand it,” she said.
___
Online:

New England Journal: http://www.nejm.org

* By Devlin Barrett, Associated Press Writer
* On Wednesday September 2, 2009, 2:57 pm EDT

WASHINGTON (AP) — Pfizer Inc., the world’s largest drug maker, will pay a record $2.3 billion civil and criminal penalty over unlawful prescription drug promotions.

Announcing the settlement Wednesday, the Justice Department said that it included the largest criminal fine in U.S. history — $1.2 billion. The agreement also included a criminal forfeiture of $105 million.

Authorities called Pfizer a repeat offender, noting it is the fourth such settlement of government charges in the last decade. They said the government will monitor the company’s conduct for the next five years to rein in the abuses.

To promote the drugs, authorities said Pfizer invited doctors to consultant meetings at resort locations, paying their expenses and providing perks.

“They were entertained with golf, massages, and other activities,” said Mike Loucks, the U.S. attorney in Massachusetts.

Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs.

Six corporate whisteblowers who first brought the misconduct to light will share $102 million of the settlement money.

FBI Assistant Director Kevin Perkins praised the whistleblowers who decided to “speak out against a corporate giant that was blatantly violating the law and misleading the public through false marketing claims.”

Associate Attorney General Thomas Perelli said the settlement illustrates ways the department “can help the American public at a time when budgets are tight and health care costs are rising.”

The overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules.

The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different than those the drugs had been approved for by federal regulators.

Use of drugs for so-called “off-label” medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration.

Bextra, one of a class of painkillers known as Cox-2 inhibitors, was pulled from the U.S. market in 2005 amid mounting evidence it raised the risk of heart attack, stroke and death.

A Pfizer subsidiary, Pharmacia and Upjohn Inc., which was acquired in 2003, has entered an agreement to plead guilty to one count of felony misbranding. The criminal case applied only to Bextra.

The $1 billion in civil penalties was related to Bextra and a number of other medicines. A portion of the civil penalty will be distributed to 49 states and the District of Columbia, according to agreements with each state’s Medicaid program.

“These agreements bring final closure to significant legal matters and help to enhance our focus on what we do best — discovering, developing and delivering innovative medicines to treat patients dealing with some of the world’s most debilitating diseases,” said Amy W. Schulman, senior vice president and general counsel of Pfizer.

Justice officials discussed details of the deal at a news conference with FBI, federal prosecutors, and Health and Human Services Department officials.

In financial filings in January, the company had indicated that it would pay $2.3 billion over allegations it had marketed the pain reliever Bextra and possibly other drugs for medical conditions different than their approved use. The civil settlement announced Wednesday also covered Pfizer’s promotions of three other drugs: blockbuster nerve pain and epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. Pfizer said the agreement with the Justice Department resolves the investigation into promotion of all those drugs, plus several related whistleblower lawsuits.

Under terms of the settlement, Pfizer must pay $1 billion to compensate Medicaid, Medicare, and other federal health care programs. Some of that money will be shared among the states: New York, for example, will receive $66 million, according to the state’s attorney general, Andrew Cuomo.

“Pfizer ripped off New Yorkers and taxpayers across the country to pad its bottom line,” Cuomo said. “Pfizer’s corrupt practices went so far as sending physicians on exotic junkets as well as wining and dining health care professionals to persuade them to prescribe the company’s drugs for patients in taxpayer-funded programs.”

Pfizer spokesman Chris Loder confirmed Wednesday that the $2.3 billion charge to the company’s earnings had been taken in the fourth quarter of 2008.

“No additional charge to the company’s earnings will be recorded in connection with this settlement,” he said.

In her statement, Schulman said: “We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls and pioneer new procedures so that we not only comply with state and federal laws, but also meet the high standards that patients, physicians and the public expect from a leading worldwide company dedicated to healing and better health.”

“Corporate integrity is an absolute priority for Pfizer,” she said, “and we will continue to take appropriate actions to further enhance our compliance practices and strengthen public trust in our company.”

When Pfizer originally disclosed the settlement figure, it also announced plans to acquire rival Wyeth for $68 billion. That deal, which would bolster Pfizer’s position as the world’s top drug maker by revenue, is expected to close before year’s end.

Shares of Pfizer dropped 14 cents to $16.24 in midday trading.

AP Business Writer Linda A. Johnson in Trenton, N.J. contributed to this report.

Schistosoma mansoni and Schistosoma japonicum both cause the debilitating disease schistomiasis.

The work has already uncovered possible targets for new treatments to combat the disease, which causes symptoms such as fever and fatigue.

The international study features in the journal Nature.

Schistosomiasis cases top 200 million every year, with 20 million people are seriously disabled by severe anaemia, chronic diarrhoea, internal bleeding and organ damage caused by the worms and their eggs, or the immune system reactions they provoke.

In sub-Saharan Africa alone it kills 280,000 people each year.

SCHISTOMIASIS

• People become infected with Schistosoma when they wade or bathe in water inhabited by tiny snails that host the parasites
• The parasites are released into the water, and use fork tails to burrow into the skin
• They travel to blood vessels that supply urinary and intestinal organs, including the liver, where they mature
• Female worms, which live inside the thicker males, release many thousands of eggs each day
• Eggs shed in urine and faeces may make their way into snail-inhabited water, where they hatch to release parasites that seek out snails to begin the cycle again

Dr Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, said: “Chronic infection with Schistosoma parasites makes life miserable for millions of people in tropical countries around the globe, and can lead to death.

“New drugs and other interventions are badly needed to reduce the impact of a disease that lowers quality of life and slows economic development.”

Since the 1980s, a cheap drug, praziquantel has been widely distributed to areas where the disease is common.

However, although the drug is effective, it does not prevent a person becoming re-infected. There is also a risk that the parasites will become resistant to it.

Therefore, developing new drug targets is important.

Enzyme targets

Researchers working on the genetic blueprint of S. masoni, the most widespread of the schistomiasis parasites, found that it was made up of 11,809 genes – about 10 times the size of the malaria parasite genome.

In particular, they identified a large number of genes which produce enzymes that break down proteins, giving the parasite its ability bore through tissue.

Subsequent analysis revealed 120 enzymes that could potentially be targeted with drugs to disrupt the worm’s metabolism.

The researchers also identified 66 drugs already on the market which might also be effective against schistomiasis.

The analysis also found that S. mansoni lacks a key enzyme needed to make essential fats, and must rely on its host to provide these – revealing a potential Achilles’ heel that could be exploited for drug development.

Researcher Dr Matthew Berriman, of the Wellcome Trust Sanger Institute, said: “This genome sequence catapults schistosomiasis research into a new era.

“It provides a foundation for understanding aspects of the parasite’s complex biology as well as a vehicle to immediately identify new targets for drug treatment.”

Fellow researcher Dr Najib El-Sayed, of the University of Maryland, said: “The genome sequence has given us, for the first time, a comprehensive view of the engines that drive the parasite, the strategies that allow it to survive in us, its human host.

“It is a catalogue of opportunities.”

In a separate study, scientists discovered that S. japonicum, which is largely confined to Asia, had even more genes.

Taking a pill to treat depression is widely believed to work by reversing a chemical imbalance.

But in this week’s Scrubbing Up health column, Dr Joanna Moncrieff, of the department of mental health sciences at University College London, says they actually put people into “drug-induced states”.

If you’ve seen a doctor with emotional problems some time over the last 20 years, you may have been told that you had a chemical imbalance, and that you needed tablets to correct it.

It’s not just doctors that think this way, either.

Magazines, newspapers, patient’s organisations and internet sites have all publicised the idea that conditions like depression, anxiety, schizophrenia and bipolar disorder can be treated by drugs that help to rectify an underlying brain problem.

People with schizophrenia and other conditions are frequently told that they need to take psychiatric medication for the rest of their lives to stabilise their brain chemicals, just like a diabetic needs to take insulin.

The trouble is there is little justification for this view of psychiatric drugs.

Altered states

First, although ideas like the serotonin theory of depression have been widely publicised, scientific research has not detected any reliable abnormalities of the serotonin system in people who are depressed.

Second, it is often said that the fact that drug treatment “works” proves that there’s an underlying biological deficiency.

“Psychoactive drugs make people feel different”

But there is another explanation for how psychiatric drugs effect people with emotional problems.

It is frequently overlooked that drugs used in psychiatry are psychoactive drugs, like alcohol and cannabis.

Psychoactive drugs make people feel different, they put people into an altered mental and physical state.

They affect everyone, regardless of whether they have a mental disorder or not.

Therefore, an alternative way of understanding how psychiatric drugs effect people is to look at the psychoactive effects they produce.

Drugs referred to as antipsychotics, for example, dampen down thoughts and emotions, which may be helpful in someone with psychosis.

Drugs like Valium produce a state of relaxation and a pleasant drowsiness, which may reduce anxiety and agitation.

Drugs labelled as “antidepressants” come from many different chemical classes and produce a variety of effects.

Prior to the 1950s, the drugs that were used for mental health problems were thought of as psychoactive drugs, which produced mainly sedative effects.

‘Informed choice’

Views about psychiatric drugs changed over the course of the 1950s and 1960s.

They gradually came to be seen as being specific treatments for specific diseases, or “magic bullets”, and their psychoactive effects were forgotten.

However, this transformation was not based on any compelling evidence.

In my view it remains more plausible that they “work” by producing drug-induced states which suppress or mask emotional problems.

“If we gave people a clearer picture drug treatment might not always be so appealing”

This doesn’t mean psychiatric drugs can’t be useful, sometimes.

But, people need to be aware of what they do and the sorts of effects they produce.

At the moment people are being encouraged to believe that taking a pill will make them feel better by reversing some defective brain process.

That sounds good. If your brain is not functioning properly, and a drug can make it work better, then it makes sense to take the pill.

If, on the other hand, we gave people a clearer picture, drug treatment might not always be so appealing.

If you told people that we have no idea what is going on in their brain, but that they could take a drug that would make them feel different and might help to suppress their thoughts and feelings, then many people might chose to avoid taking drugs if they could.

On the other hand, people who are severely disturbed or distressed might welcome these effects, at least for a time.

People need to make up their own minds about whether taking psychoactive drugs is a useful way to manage emotional problems.

To do this responsibly, however, doctors and patients need much more information about the nature of psychiatric drugs and the effects they produce.

Many people concerned about swine flu have turned to NHS Direct for help, but the telephone helpline which is supposed to take the pressure off doctors is now trying to take the pressure off itself.

The service, set up in 1997, has long been a target for criticism from doctors who have attacked what they see as its over-cautiousness.

Designed to take the strain off frontline staff, some claim it has increased workloads in the past by referring the perfectly healthy to out-of-hour doctors or A&E.

But many value its reassurance and advice and have turned to it in droves since swine flu was first reported. On Tuesday it received more than 9,000 calls relating to the virus – the highest yet.

There have been reports of lengthy waits to speak to an advisor – if you get through. Others have simply heard a recorded message.

One of the problems is that hundreds of fundamentally well people are still calling the service with their questions about swine flu, despite there being another telephone number for this purpose.

“We ended up phoning our after hours GP service and were told to bring our toddler in”

Amanda McGregor

Many others have little wrong with them and are offered advice about home care.

NHS Direct itself is now urging people to use other channels for information, notably the website’s symptom checker.

But the swine flu expert at the British Medical Association – the doctors’s union – said the service was still not effectively triaging, and that too many were ending up calling their GPs.

“NHS Direct has a place in the ordinary run of things but it is not tooled up for this job and it is struggling with the volume of calls,” says Dr Peter Holden.

“As a working GP dealing with possible cases of swine flu NHS Direct has made no difference to my work load and has even made it harder, as I am getting a lot of referrals late in the day.”

Not now

Those with children under five are specifically advised not to use the symptom checker on the NHS Direct website and contact the service directly.

“We are prioritising urgent calls so that people most in need are assessed as quickly as possible and urgent calls are being dealt with in less than 20 minutes”

Nick Chapman
Chief Executive of NHS Direct

Amanda McGregor, a mother of a one-year-old, said she decided to ring NHS Direct for advice and reassurance about her son’s high temperature.

“My husband and I couldn’t believe it when we got an answerphone saying they could not take calls because they had such a high volume of people ringing about swine flu. A voice message said information was available online.”

“We ended up phoning our after hours GP service and were told to bring our toddler in. We were then transferred to accident and emergency and prescribed Tamiflu.”

A fever is the most important symptom of swine flu – that is a temperature of 38C (100.4F) or above

There is reportedly little standard seasonal flu at the moment, so the chances are that if you have the above you do indeed have swine flu, experts say.

“Basically go out and buy a thermometer. If you have a temperature and two of the other symptoms you have flu, and should get treatment. If you’re well enough to go to work, you don’t,” says Dr Holden.

Differentiating

On Tuesday NHS Direct received nearly 9,700 swine flu related calls and its chief executive said it was now encouraging people to use other means of obtaining information.

But Nick Chapman, chief executive of NHS Direct, stressed it was not simply referring callers straight on to GPs as some have claimed, and was sorting out the mildly ill from potential cases of swine flu.

“I am extremely aware of the current pressures facing all parts of the NHS, including GPs, and want to reassure people that NHS Direct is doing all it can to help relieve this pressure. We are dealing with a significantly increased number of calls about swine flu, yesterday alone nurses spoke to over 9,500 people who were worried they had swine flu.

“For half of these people we were able to give advice on how they could treat themselves at home, without advising them to contact their GP for further assessment.

“We are prioritising urgent calls so that people most in need are assessed as quickly as possible and urgent calls are being dealt with in less than 20 minutes. If a call back is required for a non-urgent call we will tell callers how long they have to wait when they speak to someone.”

A 16-year-old girl who made UK history when, as a baby, she had a donor heart grafted onto her own has made a full recovery.

Doctors say Hannah Clark’s own heart is now in perfect working order three-and-a-half years after her “piggy-back” donor heart was removed.

Sir Magdi Yacoub, the pioneering surgeon who performed Hannah’s original transplant when she was two, said he was “surprised and delighted”.

The Lancet journal tells her story.

The original operation in 1995 saved Hannah’s life because she had cardiomyopathy – a condition which made her heart double in size and risk giving out within a year.

The donor heart was able to take over most of the role of pumping blood around Hannah’s body, effectively allowing her own beating heart to rest.

But 10 years later, at the age of 12, Hannah was experiencing serious health problems as a side effect of the immunosuppressant drugs she was taking to prevent rejection of the donor organ.

Hannah had developed tumours that had begun to spread and needed chemotherapy treatment.

For this to work, the doctors had to reduce Hannah’s immunosuppressants. But this led to her body rejecting the donor heart.

Doctors at London’s Great Ormond Street Hospital decided the only option was to disconnect the donor organ.

They found Hannah’s own heart had recovered enough to cope on its own and without daily medication.

“I would not have been here today if it wasn’t for the donor and the surgeons who did my operation. I’m really grateful”

Hannah Clark

Three years on, Hannah has made a complete recovery, say her surgeons Sir Magdi and Mr Victor Tsang.

Sir Magdi described the recovery of Hannah’s heart as “magic”.

“We did not expect her heart to recover but when it did begin to recover we were absolutely delighted.

“A heart that was not contracting at all now is functioning normally.

“It shows the possibility of recovery of the heart.”

Hannah said she felt lucky to be alive. “I would not have been here today if it wasn’t for the donor and the surgeons who did my operation. I’m really grateful.

“I don’t have to take any medicines now except an inhaler for my asthma. And I am really excited about starting a job working with animals. I couldn’t do that before because the fur could have affected my chest.”

Professor Peter Weissberg, of the British Heart Foundation, said cardiologists have long wondered whether a heart which is failing because of cardiomyopathy might be able to recover if rested.

“This seems to be exactly what has happened in Hannah’s case in which the donor heart allowed her own heart to take a rest and recover.

“This is an exciting discovery since it proves that, in some instances, a weakened heart has the capacity to recover – if it can be helped.”

He said experts were working to perfect a mechanical heart, called a ventricular assist device, that can be used in children temporarily to take over the work of a weak heart while it recovers.

A similar device already exists for adults with heart failure awaiting a donor transplant.

A House of Lords committee has said the private genetic testing industry should be more tightly controlled.

In this week’s Scrubbing Up health column, Dr Ainsley Newson, senior lecturer in biomedical ethics at the University of Bristol says failing to heed its warning would be foolish.

“

“Without a doubt, this is the most important, most wondrous map ever produced by human kind,” said President Bill Clinton in 2000 when the first human genome sequence was published.

Less than a decade later, we may soon be able to obtain our own genome sequence.

“This vast amount of information will have little meaning without professional interpretation”

For around $400 (£247), several online companies will already sell you a “snapshot” of your genome. This estimates your risk of developing certain diseases and will even predict whether you are likely to enjoy the bitterness of broccoli.

But just around the corner is whole genome sequencing: your entire DNA sequence on a memory stick.

Far from the $3 billion (£1.8 billion) spent on that first genome sequence, unlocking our DNA is now faster, more accurate and cheaper. The cost has reduced to less than $50,000 (£30,878). Soon it will be less than $1,000 (£647).

Disclaimers

Whole genome sequencing is alluring. It could offer useful predictions of our future health and susceptibility to disease, helping us better control our health. It could also predict how we will respond to a particular prescription drug.

It is, however, still limited.

We don’t know what all human genes do and how they interact with our environment.

Most genes will only give a probabilistic, not certain, indicator of whether we will develop a particular disease.

This vast amount of information will have little meaning without professional interpretation.

The companies providing whole genome sequencing recognise this and have long disclaimers stating that clinical inferences are unproven, the test is for informational use only and should not be taken as medical advice.

There are also ethical issues.

Should third parties ever have access to these data Should we test babies or children

Is it acceptable for the companies providing these tests to use your data for research How can we best ensure people understand this test

‘Doctor knows best’

One significant issue is whether testing should be offered via doctors or direct to consumers.

One company is only offering whole genome sequencing via doctors, a move criticised by those who think these tests are no different to buying over-the-counter medications in a pharmacy.

If consumers are well-informed and are simply finding out recreational information that has little health value, what is the problem What could a clinician add when this information is so uncertain

“It is irresponsible to offer testing without legitimate access to pre-test counselling and clinical support”

This may risk a paternalistic ‘doctor knows best’ attitude, denying people the right to their own genetic information.

I support people’s rights to their own genetic information, should they want it.

But to label this information as “recreational” is misleading, particularly given that one US study has already shown that consumers don’t see it this way.

‘Irresponsible’

It won’t be long until the knowledge of gene-disease associations improves.

It is irresponsible to offer testing without legitimate access to pre-test counselling and clinical support.

This could also provide a drain on NHS resources as people consult GPs, who may lack the required knowledge, for support and interpretation.

Of course it is important for people to have access to good information to influence their health care.

But we can do this while minimising the risk of harm, not least by ensuring the limitations of the test are not buried in a legalistic consent form.

Without sound clinical oversight most people will be left in charge of a significant amount of information of uncertain significance and little direction as to where to go for reliable interpretation.

Personal genomics may turn out to be an expensive way to be told to eat more greens and do more exercise but once that information becomes complex, professional clinical interpretation should be provided with the test.

This is not paternalism but responsible consumer protection.

Tens of thousands of patients with rheumatoid arthritis (RA) are not being diagnosed or treated quickly enough, says a watchdog.

The National Audit Office says over half a million people in England live with the disease, with 26,000 new cases a year – double the current estimate.

But only a tenth are treated within three months of symptoms starting, as ideally they should be.

This is because many delay seeing a GP, and RA is difficult to diagnose.

Professor Alan Silman, medical director of the Arthritis Research Campaign, said the report painted an “unsurprising but depressingly gloomy picture of the state of current patient care”.

“Early diagnosis and referral for suitable treatment is crucial as it can stop this debilitating condition in its tracks”

Neil Betteridge of Arthritis Care

Early diagnosis and treatment is key to minimising the damage and disability caused by this progressive and incurable joint disease.

But people rarely associate RA symptoms – painful, swollen or stiff joints – with a condition needing prompt medical attention.

According to the NAO, up to three quarters of people with RA delay seeing their GP beyond the recommended three months for treatment.

Even if they do seek help, on average patients see their GP four times before being referred for treatment by a specialist, by which time irreversible damage to the joints may have occurred.

A fifth have to see their GP eight or more times to get a treatment referral.

The average length of time from the onset of symptoms to treatment is nine months, and this has not improved in the past five years.

Preserving health

Only 10% of people with the disease are treated within three months of first noticing symptoms.

If this could be doubled to 20% of patients, says the NAO, at a cost to the NHS of £11m over five years, it would ultimately save the NHS money and could mean productivity gains of £31m for the economy due to reduced sick leave and lost employment.

RHEUMATOID ARTHRITIS

• RA is most common after the age of 40 but can affect any age
• Women are more than twice as likely as men to have RA
• Severe RA can shorten life expectancy by between six and 10 years

Currently, RA costs the NHS around half a billion in healthcare costs and the economy £1.8 billion a year in sick leave and work-related disability.

Over a third of people with RA will have stopped working within two years of disease onset.

The report recommends government consider a public awareness campaign to encourage more people with RA to seek help early, as well as more training for GPs to better recognise the symptoms and the need to refer suspected cases promptly.

It also flags up a need for services to help people with RA remain in work.

Awareness

Edward Leigh MP, chairman of the Committee of Public Accounts that will now consider the report and make recommendations to the Department of Health, said the NHS needed to get better at spotting people with RA and providing prompt treatment.

“The NHS should also make sure that there are appropriate support services following diagnosis, including support to help people manage this disease themselves and to remain in work,” he said.

Health minister Ann Keen said the government’s policy for caring for patients with long-term conditions – such as RA – supported the recommendations made by the NAO.

Neil Betteridge of Arthritis Care urged health chiefs to implement its recommendations as swiftly as possible.

He said: “Early diagnosis and referral for suitable treatment is crucial as it can stop this debilitating condition in its tracks.”

The National Rheumatoid Arthritis Society backed the call for a public awareness campaign.

Researchers from Taipei Medical University and Tufts University collaborated on new research presented at EB that examined the effects of almonds on risk factors for cardiovascular disease among 20 Chinese type 2 diabetic patients with mildly hyperlipidemia and treated with oral hypoglycemics. Researchers measured body fat, total cholesterol, LDL cholesterol, oxidative stress, blood sugar, insulin and inflammatory biomarkers. The 12-week clinical trial had subjects randomly assigned to receive either a NCEP Step II diet or the almond-based diet, which was the NCEP Step II diet that added almonds to replace 20 percent of the total calorie intake. At the end of the study researchers found that the almond diet led to a significant decrease in body fat by 1%, total cholesterol by 8%, and LDL cholesterol by 13%. Most importantly, researchers found that inclusion of almonds decreased blood glucose and insulin and inflammation. Alpha-Tocopherol or vitamin E levels in the blood increased, as well as the resistance of LDL cholesterol against oxidation, when tissues were tested in a laboratory environment. The NCEP Step II diet also improved cardiovascular risk factors. The changes, however, were not as clinically meaningful as those noted with the almond diet.

Twenty three almonds (1 serving) contains over 30% of the recommended daily value.

Dr. Oliver Chen, lead study author from Tufts University said, “The results of this study were very interesting, suggesting that more research needs to be conducted to evaluate the benefit of almonds on cholesterol and insulin resistance among individuals with type 2 diabetes from different populations.” He emphasized that more research will “provide us with a better understanding of how day-to-day diet, genetics and lifestyle factors may influence the overall contribution of almonds to the diet.”

Study at a Glance:

Subjects: Twenty Chinese type 2 diabetic patients with mild hyperlipidemia and treated with oral hypoglycemics.

Methods: A 12-week crossover clinical trial where subjects were randomly assigned to receive either a NCEP Step II diet or an Almond Diet. The Almond Diet was the NCEP Step II diet, except that almonds were added to replace 20 percent of the total caloric intake. Researchers measured body fat, glucose, insulin, total cholesterol, LDL cholesterol, oxidative stress and inflammatory biomarkers.

Results: Researchers found that the almond diet led to a significant decrease in body fat by 1%, total cholesterol by 8%, LDL cholesterol by 13%, blood sugar by 6.7%, and insulin by 7.9%. Changes were also noted among the inflammatory biomarkers measured, as well as the resistance of LDL against oxidation, when tissues were tested in a laboratory environment. Researchers also found an increase in alpha-tocopherol or vitamin E levels in the blood. The NCEP Step II diet also resulted in changes in cardiovascular risk factors. The changes however were not as clinically meaningful as those noted with the almond diet.

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