Older moms have a greater risk of giving birth to a child with autism, according to a study by scientists at UC Davis. 

To reach this conclusion, Janie Shelton and colleagues reviewed all births in California during the 1990s.

They found that the risk of having a child with autism jumped 18% for each 5-year increment in maternal age. A 40-year-old woman had a 50% higher risk of having an autistic child than a 25 year-old woman.
 
Previous research had identified increased paternal age as a risk factor, but this one, by far the largest of its kind, showed that father’s advanced age matters only if the mom is under 30. For older moms, the risk is predicted solely by maternal age.
 
“This study challenges a current theory in autism epidemiology that identifies the father’s age as a key factor in increasing the risk of having a child with autism,” Janie Shelton, the study’s lead author told BurrillReport. “While maternal age consistently increases the risk of autism, father’s age only contributes an increased risk when the mother is under 30 years old.”
 
“We still need to figure out what it is about older parents that puts their children at greater risk for autism and other adverse outcomes, so that we can begin to design interventions,” said Irva Hertz-Picciotto the senior author on the study.

In this regard, UC Davis scientists reported in 2008 that they found antibodies to fetal brain protein in some mothers of children with autism, but not in the mothers of normal children. Others speculate that certain environmental toxins accumulate in the body with age and may play a role as well.

The write-up appears in Autism Research.

Men who buy erectile dysfunction drugs on the Internet risk ingesting hazardous contents and may miss out on treatment for associated conditions like cardiac disease and high blood pressure, according to a study in the International Journal of Clinical Practice.

To reach these conclusions, Graham Jackson and colleagues reviewed more than 50 studies of Internet drug purchasing behavior that had been published between 1995 and 2009.

ED drugs were the most commonly counterfeited product purchased over the Internet, presumably because of their high cost and the stigma associated with the underlying condition.  As many as 2.5 million men are using counterfeit Viagra in the European Union alone, according Jackson’s group.

As many as 2.3 million ED drugs are orderred online each month worldwide, and most of them are secured without a prescription. Approximately 44% of the Viagra purchased on line is counterfeit.

Counterfeit forms of other drugs are a problem as well, Jackson’s group found. In Argentina for example, 2 pregnant women died after receiving injections of a bogus iron preparation, and 51 children died of kidney failure in Bangladesh after swallowing a Tylenol-like syrup laced with antifreeze.

Jackson’s study also revealed examples of counterfeit contraceptives, antimalarials and antibiotics.

Global sales of counterfeit drugs will reach $75 billion this year, according to the Center for Medicine in the Public Interest. That’s up 92% in just 5 years. Nearly 90% of the bogus elixirs are sold on the Internet.

“In some cases producing counterfeit medicine can be 10 times as profitable per kilogram as heroin, yet in the UK someone can face greater legal sanctions if they produce a counterfeit T-shirt,” Jackson, a London cardiologist told BurrillReport.

 “What is clear is that we need much greater public awareness of the risks of buying counterfeit drugs, as lives are at risk.”

China’s enormous investment in the field of regenerative medicine has catapulted the nation to the world’s fifth most productive contributor to the scientific literature, despite continued international condemnation of it research methods, according to a study in Regenerative Medicine.

The report was authored by Dominique McMahon and colleagues at the McLaughlin-Rotman Centre for Global Health.

It describes China’s aggressive efforts to recruit top international scientists, as well as the broadly impugned practice of administering unproven stem cell treatments to thousands of domestic and foreign patients.

Chinese researchers contributed more than 1,100 articles on the subject to peer-reviewed journals in 2008. That’s up from 37 in 2000 and more than any country in the world except the US, Germany, Japan, and the UK.

McMahon and colleagues indicate that China has recently instituted new rules governing stem cell treatments, but they need to be enforced more strictly if the nation is to repair its seedy reputation in the field.

Right now in China, more than 200 hospitals use stem cell therapy to treat patients with autism, cataracts, diabetes, Lou Gehrig’s disease, multiple sclerosis, Parkinson’s disease, stroke traumatic brain and spinal cord injury and many other conditions.
 
Yet until May 2009, China did not require such therapies to have been subjected to clinical trials designed to assess the safety and effectiveness of such therapies. 

China made the change after international experts and many Chinese researchers complained about gross violations of standard scientific research principles.

“China is an important player in regenerative medicine,” McMahon told BurrillReport. “Despite the media’s focus on stem cell tourism, the international community needs to recognize that Chinese researchers are making important contributions to the science of this field, and China should be included in international discourses on standards and regulations.”

Running in commercially-available athletic footware puts more stress on the hip, knee and ankle joints than running barefoot, according to a new study. In fact, a good jog in those designer statements puts more stress on your joints than a walk in high-heeled shoes.
 
To determine the effect of modern-day running shoes on lower extremity joint torques during running, D. Casey Kerrigan and colleagues from JKM Technologies and the University of Virginia recruited 68 healthy young adult runners (37 women) that used commercially-available running shoes.
Subjects had no history of musculoskeletal injury and ran at least 15 miles per week.

Running shoes with typical design characteristics were provided to all subjects. The subjects ran barefoot and with the shoes. Running speed was controlled by the scientists.

Kerrigan’s team analyzed their subjects’ strides using three-dimensional motion capture and ground reaction force with a tricked-out treadmill.
 
The team found that running shoes increased joint torques at the hip, knee and ankle compared with bare feet. In fact, the shoes were associated with a 54% increase in hip internal rotation torque, a 36% increase in knee flexion torque, and a 38% increase in knee varus torque.

The team also found that running shoes caused pronounced stress at anatomical sites of the knee that are prone to the development of osteoarthritis.

They speculated that their findings were caused by the elevated heel and the padding under the medial arch which are typical of modern running shoes. They also acknowledge that running shoes provide good support and protection for the foot itself.

Reducing joint torques with footwear to that of barefoot running, while providing meaningful footwear functions should be the goal of new footwear designs,” the authors wrote.

The write-up appears in PM&R.

Sanofi-Aventis has announced plans to acquire Chattem, maker of popular consumer products like Icy Hot pain reliever and Selsun Blue dandruff shampoo.

The $1.9 billion buy would be the second consumer-focused company purchased by the Paris-based drug giant in less than a year. The other one was France’s Laboratoire Oenobiol, which makes health and beauty supplements and nutritional products.

The moves should help Sanofi diversify beyond prescription drug revenue, which seems like a good idea since its 4 big drugs, Lovenox, Plavix, Ambien CR and Eloxatine will all face generic competition soon.

To accelerate its move into consumer health, Sanofi plans to release an OTC version of Allegra, its allergy drug, which has begun losing market share to Teva’s generic competitor. 
 
Even before the acquisition of Chattem and with little presence in the US consumer products market, Sanofi  managed to generate about $2 billion per year in world-wide OTC sales.
 
“The acquisition of Chattem (gives us) the ideal platform in the US consumer healthcare market,” Chris Viehbacher, CEO of Sanofi told BurrillReport. “Our ability to convert prescription medicines to OTC products will be enhanced by Chattem’s sales, marketing and distribution channels.”
 
Sanofi’s offered Chattem $93.50 per share, a 34% premium. The companies said the transaction should close in Q1, 2010. The deal would make Sanofi the fifth-largest consumer healthcare company in the world as measured by product revenues.
 
Sanofi was notably acquisitive in 2009. In addition to the purchase of Laboratoire Oenobiol, it bought BiPar Sciences and Fovea Pharmaceuticals, and a majority stake in a Russian insulin maker. Sanofi also acquired rights to an anti-MRSA vaccine produced by Syntiron and formed a research alliance with Cal Tech.

Inhibiting an enzyme known as Sirt1 in a particular region of the brain helps reduce food intake, according to scientists at Brown University. The discovery could open the door to new pharmacologic options for the management of obesity.

Sirt1 is found in many tissues including the liver and pancreas.

Earlier studies had shown that Sirt 1 had a fundamental role in cell differentiation, aging and death.

In these studies, both fasting and the antioxidant compound resveratrol-which is found in red wine–activated Sirt1 in peripheral tissues. This phenomenon was associated with improved exercise capacity, improved glucose control and prolonged survival in rats.

The Brown study, conducted by Eduardo Nillni and colleagues, is the first to study Sirt1 activity in the hypothalamus, a region of the brain known to be associated with appetite. 

Nillni’s team used 2 methods to inhibit hypothalamic Sirt1 activity: pharmacological inhibition and RNA transcription blockade. Both approaches resulted in reduced food intake and weight loss.

The scientists also found that fasting increases hypothalamic expression of the Sirt1 gene, which makes it even more likely that Sirt1 plays a central role in moderating appetite and hunger in mammals.

Nillni now plans to study how obesity affects Sirt1 activity in the brain.

The write-up is in PloS One.

Drug induced increases in levels of the brain neurotransmitter norepinephrine can overcome memory problems and improve cognitive development in mice with genetically-engineered Down syndrome, according to scientists at Stanford.

Ahmad Salehi and colleagues postulate that similar interventions, if applied early enough in children with Down syndrome, might improve their cognitive development as well.
 
Their write-up appears in Science Translational Medicine.

In the article, Salehi’s group showed that drugs which enhanced norepinephrine signaling in the brains of the genetically engineered mice rapidly restored cognitive function, enabling them to handle simple challenges like building a nest.

The treated mice could make nests as well as normal mice. Untreated mice were unable to do so. The beneficial effects became apparent just hours after treatment was initiated. They waned quickly following discontinuation of the drugs.
 
Salehi’s genetically-engineered mice exhibited early degeneration of the locus ceruleus, a part of the brain that supplies norepinephrine to the hippocampus, which is involved with memory formation. The same findings have been demonstrated in humans with Down syndrome.

Several drugs that have been approved by the FDA for treatment of depression and ADHD have the same effects on brain norepinephrine levels as those used in the Stanford study. Because these drugs have proven to be safe in humans (though not infants), Salehi told BurrillReport he hoped his results would quickly lead to human trials.
 
Previous efforts to modify the course of Down syndrome with drugs have focused on acetylcholine, a separate neurotransmitter that also acts on the hippocampus.

Baby Boomers that are just now entering their sixties are likely to be more burdened by disabilities than their counterparts in earlier generations, according to UCLA scientists. If their projections prove accurate, it could have a devastating impact on the nation’s health system.

To reach these conclusions, Teresa Seeman and colleagues queried data from the National Health and Nutrition Examination Surveys (NHANES) for the years 1988 and 1999.

They looked at 4 areas: activities of daily living, like walking from room to room; instrumental activities like doing chores; functional limitations like kneeling or stooping; and mobility, which includes walking one-quarter mile without a rest.

The study focused on adults born between 1930 and 1944, because this group could offer the most insight into the problems that will be associated with Baby Boomers who are now entering their 60s.

The researchers found that between 1988 and 1999, disability among people in their sixties rose 40-70% percent in each of the 4 areas except functional limitations, even after controlling for socioeconomic characteristics, health status and weight.

The increases were pronounced in non-white people, a subset of the US population that is growing most rapidly and that is known to have a higher incidence of obesity and lower socioeconomic status. These factors are associated with an increased risk of functional limitations and disabilities.

“If this is true, it’s something we need to address,” Teresa Seeman, the study’s principal investigator told BurrillReport. “If this trend continues unchecked, it will put increasing pressure on our society to take care of these disabled individuals.”

The study will appear in the January issue of the American Journal of Public Health.

Ever wonder why there isn’t a birth control pill for men?

Part of the reason is that the physiological mechanisms governing sperm production in men are less well understood than those governing ovulation in women.

Androgens are known to play a key role in normal sperm production and male fertility generally, but the mechanism by which androgens exert these effects had been largely unknown.

Now, a recent paper published in the FASEB Journal may have shed some light on the matter.

In the paper, Michelle Welsh and colleagues at the Centre for Reproductive Biology in Edinburgh studied androgen levels and sperm production in 2 groups of mice. The first group was normal, but the second had been engineered such that the peritubular myeloid cells in their testes lacked a particular gene that codes for an androgen hormone receptor.

In latter group, testis weight did not increase normally at puberty, and by the time they matured to adulthood they could produce only about 14% as many sperm cells as their normal counterparts. The findings were not explained by differences in testosterone, luteinizing hormone, or follicle-stimulating hormone levels.

The authors concluded that androgen action on the peritubular myeloid cells was therefore essential for normal testis function, spermatogenesis, and fertility in male mice, and seemed quite confident in their write-up that the findings would be easily reproduced in other mammals including humans.

“This study…could provide new insight for the development of new treatments for male infertility and perhaps new male contraceptives,” Welch told BurrillReport.
 
“Not only does this research pinpoint androgenic hormones and their cellular receptors as prime targets for the development of new birth control drugs, but it promises to speed the development of new agents to boost sperm production,” added Gerald Weissmann, who edits the FASEB Journal.

Most people have assumed that direct-to-consumer advertising has helped drive up the cost of drugs, but there really hadn’t been much proof of that. Until now, that is.

The proof comes in the form of a study published in the Archives of Internal Medicine.

In the study, Michael Law of the University of British Columbia and others looked at US sales of Plavix, the $4 billion clot-busting blockbuster co-marketed by BMS and Sanofi-Aventis for the prevention of recurrent heart attacks and strokes, and thrombotic complications following stent placement.

Plavix was introduced to the US market in 1998. DTC advertising for the drug began 3 years later, and exceeded $350 million dollars over the next 4 years.

Law’s group queried pharmacy data from 27 Medicaid programs from 1999 through 2005 to analyze changes in Plavix prescription volume, the cost per unit dispensed, and total pharmacy expenditures before and after DTC advertising was introduced.

The scientists detected no change in the preexisting trend in the number of Plavix prescriptions written after DTC advertising was introduced.

They did, however, detect a sudden, sustained increase in cost per unit of the drug, of $0.40 per unit dispensed which coincided with the introduction of DTC advertising.

This resulted in an incremental cost of $40.58 per 1000 Medicaid enrollees per quarter, or an additional $207 million in total pharmacy expenditures.

“The key issue is whether advertising to consumers, which has risen 330% in the last 10 years in the US, contributes to the significant cost increases in publicly funded health insurance programs such as Medicaid,” Stephen Soumerai told BurrillReport.

Add Selective Androgen Receptor Modulators, or SARMs to the list of substances used by athletes to enhance competitive performance.

SARMs have not yet been approved for any indication by any regulatory agency in the world. Nevertheless, scientists at the German Sport University in Cologne have shown there already is an Internet-based black market for the substances, which are believed to provide benefits similar to anabolic steroids with fewer side effects.

Many drug companies are developing SARMs for the treatment of osteoporosis, benign prostatic hyperplasia, and appetite loss associated with cancer.
 
Using mass spectroscopy, Mario Thevis and colleagues recently demonstrated the presence of Andarine, a potent SARM in containers labeled as green tea extract and face moisturizer that were purchased over the Internet for $100.

Their write-up appears in Drug Testing and Analysis.

“This product with considerable anabolic properties is readily available without sufficient research on its undesirable effects,” Thevis told BurrillReport. “This is especially significant where uncontrolled dosing is applied and drug impurities with unknown effects are present in considerable amounts as observed in the studied material.”

Thevis presented his findings at the Conference of Parties to the International Convention against Doping in Sport, which was held in Paris 2 months ago.

In 2008, the World Anti-Doping Agency (WADA) prohibited the use of SARMs in sports. WADA President John Fahey said at the time that in order to rid sport of doping, government agencies must adopt laws and regulations to combat the trafficking and supply of illegal substances.

Drugs used to reverse anemia in cancer and kidney failure patients are largely ineffective and markedly increase the risk of blood clots, according to a study by scientists at Columbia University Medical Center.

To reach this conclusion, Dawn Hershman and colleagues studied use of the so-called erythropoiesis stimulating agents (ESAs) in more than 50,000 patients that had been diagnosed with cancer.

In these patients, ESAs did not reduce blood transfusion requirements caused by chemotherapy, but they did jack up the risk of deep venous thrombosis and pulmonary embolism.

Hershman’s study population included patients that were at least 65 years of age and had been diagnosed with cancers of the breast, colon and lung. ESAs are used frequently in such patients as adjuncts to chemotherapy.

Survival was not impacted by the ESAs.

The number of patients receiving ESAs jumped 10-fold from 1991 through 2002. By that time, nearly half of all cancer patients were receiving them.

“This analysis confirms the association between ESAs and venous thromboembolism, which was observed in previous meta-analysis,” Hershman told BurillReport. “This data is from community practice – real-life clinical settings – where you see things that wouldn’t necessarily show-up in a short-term, 12-week study.”

Leading ESAs include Amgen’s Aranesp and Epogen, and Johnson & Johnson’s Procrit. Sales of these drugs topped $10 billion in 2006 in the US alone.

The meta-analysis mentioned above prompted the FDA to issue a black-box warning regarding the potential for tumor promotion, venous thromboembolism and decreased survival with ESAs. The warning suggested that ESAs should be used only for specific tumors and only when hemoglobin levels dropped below certain levels.

The write-up appears in the Journal of the National Cancer Institute.

Looking for another reason to avoid the Greasy Spoon on your lunch break?

Oxford University scientists have provided a doozy. In their study, rats receiving a fat-laden diet exhibited a 50% reduction in exercise capacity and diminished cognitive skills after just 9 days.

The findings could have implications for Average Joes who eat Sloppy Joes for lunch, athletes in search of an edge, and people at risk for metabolic syndrome and diabetes, say the authors who published their findings in the FASEB journal.
 
“We found that rats, when switched to a high-fat diet from their standard low-fat feed, showed a surprisingly quick reduction in their physical performance,” lead author Andrew Murray told BurrillReport.
 
The physiology behind the observations is fairly well understood. Exercise endurance is a function of the amount of oxygen that can be delivered to muscles and the efficiency with which muscles can extract the energy contained within the chemical bonds of the nutrients supplied to them (a process known as oxidation)

Fat oxidation is less efficient than the oxidation of simple carbohydrates like glucose.

For their study, Murray and Co. fed 42 rats a standard diet containing 7.5% fat, and measured exercise capacity as the maximal time they were able to run on a treadmill. They assessed short-term memory in the subjects using a maze task.

The scientists then switched half the rats to a diet in which 55% of the calories were derived from fat and reassessed the rats’ endurance and cognitive abilities.

Junk food diets can easily approach the 55% fat content used by the scientists.
 
By day 9, rats on the high fat diet managed to run only half as far as their counterparts. They were also making mistakes about 17% earlier in the maze task, suggesting diminished cognitive skills.

Cal Tech scientists may have figured out why some people have a notably annoying tendency to get too close during conversations, on subway trains or in restrooms.

The culprit turns out to be a malfunction in an almond-sized structure known as the amygdala, which is located in both temporal lobes of the brain. The amygdala processes negative emotions like anger and fear, but its role in social interaction had not previously been studied.

Daniel Kennedy, Ralph Adolphs and colleagus made the association by studying a 42-year-old woman known as SM, who has severe, isolated damage to her amygdala.

The scientists had known that SM couldn’t recognize fear in the expressions of others, or judge their trustworthiness, and had shown these abnormalities to be caused by her amygdala lesions.
 
While observing SM over time, Adolphs also noticed that she seemed to be too friendly, and frequently violated what others perceived to be their own personal space.

“She is extremely friendly, and she wants to approach people more than normal. It’s something that immediately becomes apparent as you interact with her,” Kennedy told BurrillReport.
 
So the scientists decided to compare SM’s sense of personal space to normal volunteers using the stop-distance technique, in which subjects approach a person until they reach a point where they feel most comfortable, and this distance is recorded.

Among the normal volunteers, the mean preferred distance was about 2 feet, but SM came in much tighter than that, about a foot. And unlike normal subjects who reported feeling uncomfortable when the experimenter approached to a distance within their preferred range, SM never became uncomfortable.

Even cheek to cheek, she was relaxed, and her feelings changed not a whit regardless of who the experimenter was or how well she knew them.

The write-up appears in Nature Neuroscience.

Java junkies rejoice!

New studies suggest that caffeine reduces cerebral beta amyloid deposits and improves memory and overall cognitive function in aged mice genetically altered to develop a murine form of Alzheimer’s disease.

What is more, reductions in levels of the protein marker and the improved behavioral performance showed up after the mice received the equivalent of just 2 Grande Starbucks per day for 2 months.

To reach these conclusions, Gary Arendash and colleagues at the University of South Florida studied 55 mice.

After cognitive testing confirmed the little fellows were losing their marbles, the scientists added caffeine to the drinking water of half the subjects. The unlucky others just got the water.

After 2 months, the mice that received the Joe outperformed their counterparts on a battery of  memory and cognitive skills, and in fact their recall essentially matched that of normal, age-matched mice.

The scientists then showed that brains of the caffeinated mice had nearly 50% less beta amyloid, the notorious plaque-building protein that is the pathologic sine qua non of Alzheimer’s disease.

“The findings provide evidence that caffeine could be a viable treatment for established Alzheimer’s disease, and not simply a protective strategy,” Arendash told BurrillReport. “Caffeine is a safe drug for most people, it easily enters the brain, and it appears to directly affect the disease process.”

Arendash’s group performed follow-up experiments which suggested the wonder drug appears to work by down-regulating the process by which beta amyloid is produced, and by reducing cerebral inflammatory changes that stimulate beta amyloid production.

The write-up appears in the Journal of Alzheimer’s Disease. The scientists hope to begin human trials shortly. Getting people to volunteer for the studies is not expected to be problematic.

For legions parents that have endured far too many sleepless nights trying to console colicky babies, relief might be on the way.

Scientists think they’ve identified a bacterium that causes the nerve-racking condition, in which otherwise healthy babies scream for hours.

Colic affects nearly 15% of all infants in the US.

Pediatrics professor J. Marc Rhoads and colleagues at the University of Texas are proposing that Klebsiella is the culprit. The gram-negative bacterium resides in the gastrointestinal tracts of humans of every age, but in colicky babies only, the bug seems to trigger an inflammatory reaction in the intestines.

In non-colicky babies, Klebsiella causes no such disturbance.

Previous theories held that babies receiving cow’s milk were more likely to suffer from colic, but research on the matter has failed to support that claim. The colicky babies in Rhoads’ study for example, included some who were fed breast milk and some who received formula.

Rhoads speculated that colic might actually be a precursor to other gastrointestinal maladies ranging from  irritable bowel syndrome to Celiac disease. “Inflammation in the gut of colicky infants closely compared to levels in patients with inflammatory bowel disease,” he told BurrillReport.

The write-up appears in Pediatrics.

Typicially, pediatricians prescribe hypoallergenic formulas for the treatment of colic, but as harried parents can attest, the approach is often ineffective.

Rhoads believes his teams’ discovery might eventually save lives.

“Colic can be a dangerous situation for a baby. The parent’s frustration over the crying can lead to maternal frustration, post-partum depression, and even thoughts of harming the baby,” he told Burrill.

“More than half of infanticides fall into the age category of colic. We may be able to prevent deaths if we can find a treatment.”