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16 April 2009

Aspirin and similar drugs may be associated with brain microbleeds in older adults

Individuals who take aspirin or other medications that prevent blood clotting by inhibiting the accumulation of platelets appear more likely to have tiny, asymptomatic areas of bleeding in the brain, according to a report posted online today that will appear in the June print issue of Archives of Neurology, one of the JAMA/Archives journals.

Cerebral microbleeds—small deposits of the iron-storing protein hemosiderin in the brain—may be a sign of cerebral small-vessel disease, according to background information in the article. This condition, common among older adults, occurs when the walls of blood vessels in the brain become weakened. When microbleeds occur in certain brain areas, they may indicate a type of small vessel disease known as cerebral amyloid angiopathy, in which the accumulation of amyloid (a protein often related to Alzheimer's disease) causes degeneration of smooth muscle cells and increases the susceptibility of blood vessels to ruptures and hemorrhages.
Meike W. Vernooij, M.D., and colleagues at Erasmus MC University Medical Center, Rotterdam, the Netherlands, investigated the relationship between cerebral microbleeds and the use of anti-clotting medications in 1,062 individuals without dementia involved in the Rotterdam Scan Study. Participants (average age 69.6) underwent magnetic resonance imaging examinations in 2005 and 2006. Pharmacy records were used to assess whether any of the individuals took anti-clotting drugs. These included aspirin and carbasalate calcium—called platelet aggregation inhibitors because they prevent the accumulation of platelets that form blood clots.

In the years before MRI, 363 (34.2 percent) of the participants had used any anti-clotting drugs, including 245 (23.1 percent) who took platelet aggregation inhibitors (67 taking aspirin and 141 taking carbasalate calcium). Compared with patients who did not use anti-clotting drugs, those who took aspirin or carbasalate calcium were more likely to have cerebral microbleeds visible on MRI. This association was particularly strong among individuals taking these drugs at higher doses, typically used to treat or prevent heart disease. Microbleeds in the frontal lobe were more common among aspirin users than carbasalate calcium users. There was no association between other types of anti-clotting drugs and cerebral microbleeds.

"There is currently major interest in bleeding risks with the use of antithrombotic or thrombolytic treatment in persons who have microbleeds that are apparent on MRI because this may affect treatment in patients with cardiovascular or cerebrovascular disease," the authors write. "The cross-sectional design of our analyses prohibited an investigation of whether persons with cerebral microbleeds are at increased risk for symptomatic hemorrhage [excessive bleeding] when using platelet aggregation inhibitors."

The beneficial effects of anti-clotting drugs for individuals at risk for heart attack and stroke typically outweigh any risks of bleeding, they note. "Nevertheless, it may be that in selected persons (e.g., those with signs of cerebral amyloid angiopathy), this risk-benefit ratio may differ for certain drugs (e.g., aspirin), thus influencing treatment decision," they conclude.


(Arch Neurol. 2009;66[6]:(doi:10.1001/archneurol.2009.42). Available pre-embargo to the media at

Diabetes 'impact on brain power'

Failure to control type 2 diabetes may have a long-term impact on the brain, research has suggested.

Severe hypoglycaemic episodes - hypos - occur when blood sugar levels drop dangerously low.

A University of Edinburgh team found they may lead to poorer memory and diminished brain power.
The study, based on 1,066 people with type 2 diabetes aged between 60 and 75, was presented at a conference of the charity Diabetes UK.
The volunteers completed seven tests assessing mental abilities such as memory, logic and concentration.

The 113 people who had previously experienced severe hypos scored lower than the rest of the group.

They performed poorly in tests of their general mental ability, and vocabulary.

There are at least 670,000 people in England aged between 60 and 75 years old who have Type 2 diabetes and around a third of them could be at risk of a hypo.

Possible reasons

Lead researcher Dr Jackie Price said: "Either hypos lead to cognitive decline, or cognitive decline makes it more difficult for people to manage their diabetes, which in turn causes more hypos.

"A third explanation could be that a third unidentified factor is causing both the hypos and the cognitive decline.

"We are carrying out more research to establish which explanation is the most likely."

Dr Iain Frame, director of research at Diabetes UK, said: "This study reinforces previous evidence which suggests that poorly controlled diabetes affects the functioning of the brain.

"We already know that type 2 diabetes increases the risk of developing Alzheimer's disease, which is a type of dementia, and this research adds another piece to a very complex jigsaw puzzle.

"However, more research is needed before we can come to any firm conclusions."

There are 2.5 million people diagnosed with diabetes in the UK and up to 500,000 who have type 2 diabetes but do not know it.

It is predicted that by 2025 there will be up to four million people with diabetes in the UK.

The New 'Epigenetics:' Poor Nutrition In The Womb Causes Permanent Genetic Changes In Offspring

ScienceDaily (Apr. 14, 2009) — The new science of epigenetics explains how genes can be modified by the environment, and a prime result of epigenetic inquiry has just been published online in The FASEB Journal: You are what your mother did not eat during pregnancy. In the research report, scientists from the University of Utah show that rat fetuses receiving poor nutrition in the womb become genetically primed to be born into an environment lacking proper nutrition.
As a result of this genetic adaptation, the rats were likely to grow to smaller sizes than their normal counterparts. At the same time, they were also at higher risk for a host of health problems throughout their lives, such as diabetes, growth retardation, cardiovascular disease, obesity, and neurodevelopmental delays, among others. Although the study involved rats, the genes and cellular mechanisms involved are the same as those in humans.

"Our study emphasizes that maternal–fetal health influences multiple healthcare issues across generations," said Robert Lane, professor of pediatric neonatology at the University of Utah, and one of the senior researchers involved in the study. "To reduce adult diseases such as diabetes, obesity, and cardiovascular disease, we need to understand how the maternal–fetal environment influences the health of offspring."

The scientists made this discovery through experiments involving two groups of rats. The first group was normal. The second group had the delivery of nutrients from their mothers' placentas restricted in a way that is equivalent to preeclampsia. The rats were examined right after birth and again at 21 days (21 days is essentially a preadolescent rat) to measure the amount of a protein, called IGF-1, that promotes normal development and growth in rats and humans. They found that the lack of nutrients caused the gene responsible for IGF-1 to significantly reduce the amount of IGF-1 produced in the body before and after birth.

"The new 'epigenetics' has taught us how nature is changed by nurture," said Gerald Weissmann, M.D., Editor-in-Chief of The FASEB Journal. "The jury's in and, yes, expectant moms really are eating for two. This study shows not only that we need to address problems such as preeclampsia during pregnancy, but also that prenatal care is far more important than anyone could have imagined a decade ago."

Journal reference:

1. Qi Fu, Xing Yu, Christopher W. Callaway, Robert H. Lane, and Robert A. McKnight. Epigenetics: intrauterine growth retardation (IUGR) modifies the histone code along the rat hepatic IGF-1 gene. FASEB J., DOI: 10.1096/fj.08-124768

15 April 2009

Fears Spread Over Plan to Inject Babies With Hepatitis B Vaccine

Government health experts are considering whether to add the vaccine to a jab given to children at eight weeks.

The option, to be discussed by the Joint Committee on Vaccination and Immunisation in June, would create a six-in-one vaccine that would also immunise against diphtheria, tetanus, whooping cough, polio and Hib disease – a form of pneumonia.

It comes in response to rising levels in Britain of Hepatitis B, a blood infection that can lead to liver cancer.

Campaign groups said the move would worry parents already concerned that children are given too many vaccines, many of which have been linked to potentially harmful side-effects.

Children are already given 32 vaccines before they even reach school age, spread across 11 jabs including the MMR against measles, mumps and rubella once claimed to be linked to the onset of autism. The addition of the Hepatitis B immunisation to the first jab would bring the total of vaccines to 33.

A Harvard study found those vaccinated against Hepatitis B are at increased risk of multiple sclerosis, although it did not determine whether the jab caused the disease or speeded up the onset in those already destined to have it.

Jonathan Harris, of campaign group Jabs, said: "The vaccine has been linked to multiple sclerosis and Chronic Fatigue Syndrome and parents will understandably question the need to add it to what is an already crowded schedule of jabs. There will be a great deal of public concern about this and, as usual, very little consultation."

Estimates suggest the number infected by Hepatitis B in Britain almost doubled between 2002 and 2007, to 326,000. More than half of those cases were immigrants from Africa, Asia, Russia and the new EU nations.

The British Medical Association and the charity Hepatitis Foundation UK have previously called for all babies to be immunised against Hepatitis B, bringing the UK in line with World Health Organisation policy.

Andrew Wilson, a trustee of Hepatitis Foundation UK, said: "The trouble is hepatitis B is known as a silent killer because there are often no symptoms until real damage has been done. Parents' concerns are understandable but a child vaccinated at a young age will always be protected."

The virus can be spread by only a tiny amount of blood through cuts and grazes, but is most commonly transmitted by unprotected sex and needle sharing among drug addicts.

Andrew Thomson, of the BMA's Board of Science, said Hepatitis B infection rates were spiralling and that treating the infection was costing the NHS millions of pounds.

High risk areas for the disease include South Asia, Africa and parts of Eastern Europe. Many migrants from these areas settle in Britain. The condition can kill five per cent of those who contract it.

A spokeswoman for the Department of Health said: "The safety of children is always paramount whenever decisions are taken regarding what vaccines are included as part of the child vaccination programme.

"We do target hepatitis B immunisation at groups at increased risk of infection such as babies born to infected mothers, injecting drug users, those at risk of sexual exposure, and healthcare workers.

"The Joint Committee on Vaccination and Immunisation (JCVI), the independent expert advisory committee, keeps all vaccine issues under review including Hepatitis B."

From this month, the Joint Committee on Vaccination and Immunisation has greater powers to decide UK vaccine policy.

Medical Researchers Coming to Grips With Conflicts of Interest

By Julie Steenhuysen

CHICAGO (Reuters) - Dr. Bruce Psaty of University of Washington in Seattle knows how easy it can be to fall under the spell of a friendly relationship with drug companies.

As an assistant professor, he published an article on using beta-blockers to treat high blood pressure that caught the attention of the pharmaceutical industry.

"My family and I were invited to a first-class resort, where I presented the results at a sponsored conference," Psaty wrote in a commentary this week in the Journal of the American Medical Association.

He agreed to help develop a set of slides on beta-blockers and soon found himself suggesting that the drug company's studies be featured, in part because he felt "a kind of social duty to reciprocate both the kindness and the investment made by the sponsor in the slide set."

Psaty said his own story illustrates the subtleties of conflicts of interest. He is dissatisfied with the current debate among doctors, spurred by reports last year by Iowa Republican Senator Charles Grassley that a prominent Harvard psychiatrist failed to fully disclose hefty payments from drug companies.

"The debate has not been terribly fruitful," Psaty said in a telephone interview. He said conflicts are sometimes hard to recognize, pointing to the work of Dan Ariely, a behavioral economist at Duke University in North Carolina.

Ariely's research suggests that most people are comfortable with just a little bit of cheating, without considering themselves dishonest. He says subtle conflicts of interest often color decision making, yet most people -- especially doctors -- think they are immune.


"It's human instinct," Ariely said in a telephone interview. "If someone does something nice -- gives you $5 million in a research grant -- don't you want to do something nice back to them?"

Ariely said return favors could come in the form of excluding a sicker patient from a clinical trial, which might affect the study results. "Not on purpose, but I'm trying to help my friends, just a little bit."

Several states including Massachusetts, Minnesota and Vermont are tightening restrictions on gifts to doctors in the hopes of preventing such conflicts.

And a bill introduced by Senators Grassley and Wisconsin Democrat Herb Kohl would compel doctors to disclose their financial ties with drug companies or face stiff fines.

Psaty said such laws may curb some financial conflicts, but a bigger challenge will be addressing the influence drugmakers have over company-funded research supporting the safety and effectiveness of the drugs they make.

Psaty said he accepts no funding from drug companies for his research, but short of having all clinical trials funded with public money, he suggests doctors look for red flags in studies that might indicate bias.

"Was the question a good question? Did they set the study up right? Did they use the weakest possible comparator to make a drug look good in a trial?" he said.

And when a medical journal editorial disagrees with the primary interpretation of the author, "that is a potential marker of a study where there may been some bias from conflict of interest," he said.

(Editing by Maggie Fox and Sandra Maler)

96 Percent of Patients Don't Discuss Drug Prices With Their Doctors

Most patients never talk about price when getting a drug prescription from their doctor, and few confront the actual price of their drugs before it's time to pay at the pharmacy, according to a poll released by Consumers Union.

The group is urging doctors and patients to factor in the price of drugs when deciding on treatments. They're pointing to generics, which in many cases are just as effective and safe for the fraction of the price of a brand-name alternative.

"If cost is an issue, have a heart-to-heart with your doctor and make sure he or she knows that costs are an issue," says John Santa, MD, an internist and director of the Consumer Reports health rating center.

Consumers Union released a poll of roughly 2,000 adults showing that just 4% discussed price when getting a drug prescription from their doctor; as many as 60% of those polled learned about the price of their drugs for the first time at the pharmacy register.

The poll was conducted between Jan. 15 and Jan. 19; it has a margin of error of plus or minus 3.4 percentage points.

The poll confirms what many other studies have shown: that many patients regularly resort to measures such as cutting pills in half, skipping doses, or skipping medication altogether in an effort to save on medical bills.

"Sticker shock is really taking a toll on American consumers," says Ed Farrell, director of national research at Consumer Reports.

The magazine's latest issue has a guide to cheaper generics in about 20 drug classes, including drugs for high blood pressure, depression, and high cholesterol.
Comparative Effectiveness Research

Consumers Union is backing an Obama administration plan to boost research directly comparing the effectiveness of different drugs, devices, and other treatments. The hope is to find less-expensive treatments or tests that work as well as the more expensive versions.

Congress spent $1.1 billion in the economic stimulus bill to jump-start so-called "comparative effectiveness" research at the federal level.

But comparative effectiveness research -- or at least the way the government and insurers might use it -- is controversial.

Drugmakers, device manufacturers, and other industry groups worry that it could be used as an excuse to ration health care. They warn that the government and insurers could decide to pay only for the cheapest treatments, impairing the decisions doctors and patients can make.

Robert Moffitt, director of the Center for Health Policy Studies at the Heritage Foundation, says few are opposed to getting the best treatments for the best price. "Who the heck is against that?" he says.

"The issue is a federal infrastructure that will give a seal of approval about what to do," he says. He urges doctors and patients to have "a profound distrust" of how the research could be used as Washington tries to find a way to save hundreds of billions of dollars as part of overall health reform.

Sen. Tom Coburn, R-Okla., was also critical of the proposal. "They're going to look at cost, just like England does, and say, we can't afford it so we won't do it," he says. Coburn is a doctor and a member of the Senate Committee on Health, Education, Labor, and Pensions.

Policy makers have not yet decided how health programs like Medicare will use head-to-head research for drugs and treatments, or how the data will fit into overall health reform.

"The government has a real opportunity to provide neutral, credible, transparent public information for everybody to see," Santa says.