NSAIDs Linked to Erectile Dysfunction

April 8th, 2011 | 2 Comments | Source: BurrillReport, J. Urology, MedPageToday

The use of Motrin, Aleve and other non-steroidal anti-inflammatory drugs (NSAIDS) is associated with erectile dysfunction, according to a study by scientists affiliated with Kaiser Permanente.

The apparent link surprised the scientists. They had hypothesized that the commonly used pain-killers would actually reduce the risk of erectile dysfunction since NSAIDS protect against heart disease, which has in turn been linked to the troubling condition.

To reach their surprising conclusion, Steven Jacobsen and colleagues used data from Kaiser’s HealthConnect EHR, an associated pharmacy database, and self-reports about NSAID use and erectile dysfunction from an ethnically diverse population of 80,966 men between the ages of 45 and 69.

After controlling for age, ethnicity, race, body mass index, diabetes, smoking status, hypertension, high cholesterol and coronary artery disease, the scientists found that men who used NSAIDS at least 3 times per day for at least 3 months were 2.4 times more likely to experience erectile dysfunction than those who did not consume them on a regular basis. The link persisted across all age categories.

Remarkable in its own right was the finding that overall, 29% of the men in the study reported some level of erectile dysfunction.

The authors emphasized that their findings do not prove that NSAID use causes erectile dysfunction. For example, the study findings could have been confounded by factors not considered by the scientists (such as subclinical disease or the severity of the comorbid conditions that were studied), and the chance that NSAID use was actually an indicator for other conditions that caused erectile dysfunction.

In addition, the scientists recognized that their study had some limitations. These included an inability to temporally link NSAID use and the development of ED, and possible selection bias. (more…)



Japanese Dog Sniffs-out Colon Cancer

March 14th, 2011 | No Comments | Source: Boston Globe, BurrillReport, Gut

Who said you can’t teach an old dog new tricks?

Japanese scientists have trained an 8-year-old Labrador retriever to detect colon cancer by sniffing samples of breath and stool from people. According to their findings in the journal Gut, the dog nailed the diagnosis 95% of the time on the breath test and 98% of the time on the stool test, a performance that compares favorably with colonoscopy, the expensive, distasteful state-of-the art for such matters. 

The Black Lab was trained at the St. Sugar Cancer Sniffing Dog Training Center in Chiba, Japan. After training was complete, a team led by Hideto Sonada presented the dog a series of 5 sample stations, one of which contained a specimen from a patient with colon cancer. The other 4 came either from volunteers with no history of cancer or patients with a past history of cancer.

Amazingly, the dog correctly identified the cancerous sample in 37 out of 38 stool tests, and in 33 out of 36 breath tests. It seemed to perform better in samples derived from patients that had early stage disease. The dog’s talents were unaffected by colonic polyps, inflammatory disease, cigarette smoking, or the presence of blood in the stool.

This performance is light-years better than widely-available colon cancer-screening procedures. For example, the fecal occult blood test picks-up early-stage cancer only about 10% of the time.

The results in this case were consistent with previous studies in which dogs could detect cancers of the bladder, breast and ovary, as well as melanomas. This dog’s particular skill at detecting early-stage cancer was unique, however. (more…)



Super-Chickens in Fight Against Avian Flu

February 24th, 2011 | 1 Comment | Source: BurrillReport, Science

In 2003 and 2004, bird flu outbreaks devastated the economies of several Southeast Asian countries. More than 140 million birds either succumbed to the virus or were culled by humans in an attempt to control the epidemic. Poultry producers lost more than $10 billion.

Thankfully, those strains of avian flu weren’t adept at infecting humans. If a future strain manages to do so in a big way, the resulting pandemic could cost the global economy $1.25 trillion.

Those predictions have ruffled feathers among politicians and scientists alike, and a serious effort has begun to prevent such an occurrence. Unfortunately, research on anti-viral drugs and vaccines is going nowhere fast.

Now however, scientists at the Universities of Cambridge and Edinburgh have chosen to attack the problem in a different way: they’ve created a better chicken.

In a paper published in Science, Laurence Tiley and colleagues report having genetically re-engineered the standard chicken into a version that doesn’t transmit avian flu to its coop-mates. The scientists assert their super-chicken may prevent outbreaks of avian flu among birds and yes, reduce the chances that the virus could jump to humans, who have no immunity to bird flu.

“Preventing virus transmission in chickens should reduce the economic impact of the disease and reduce the risk posed to people exposed to the infected birds,” Tiley said in an interview. “The genetic modification we describe is a significant first step along the path to developing chickens that are completely resistant to avian flu.”

To produce their super-chickens, Tiley’s group introduced a so-called RNA-expression cassette into their DNA. The cassette prompted the chickens to produce a hairpin-shaped piece of RNA that essentially tricks a viral enzyme known as polymerase into biding with it, rather than the native viral genome. This renders the enzyme useless and prevents the virus from replicating itself. (more…)



2010: A Mixed-Bag for Big Pharma

January 24th, 2011 | No Comments | Source: BurrillReport, Wall Street Journal

Last year was another lackluster one for the drug and biotech industries, as the FDA seemed to ratchet-up its scrutiny of trial data and set the bar higher on requirements for drug efficacy. Overall, the regulatory agency approved 24 new drugs in 2010, which was slightly down from the 26 it approved in 2009 and dead-even with the 24 it approved in 2008. Only 17 were approved by the FDA in 2007

Two of the newly approved drugs appear to have a shot at becoming blockbusters: these are Gilenya, which is Novartis’ pill for multiple sclerosis, and Provenge, Dendreon’s injectable treatment for advanced prostate cancer. A pair of much-anticipated obesity drugs, Arena Pharmaceuticals’ lorcaserin and Vivus’ Qnexa were rejected by the FDA, as were many others. Perhaps the biggest news however, focused on the FDA’s handling of safety issues surrounding drugs it had approved in previous years. Here’s a summary of some winners and losers:

Newly Approved Drugs
Multiple Sclerosis-Patients with multiple sclerosis did have a good deal to cheer about last year. In addition to Gilenya, the FDA approved Ampyra (Acorda Therapeutics) to improve gait disturbances in MS patients.

Advanced Prostate Cancer-Dendreon finally won FDA approval for its cancer-fighting vaccine, Provenge. The regulatory agency had previously rejected the drug and required that additional trials be performed, despite early clinical trials which were generally positive.

Stroke Prevention-Drug makers have been vying for years to replace warfarin, the widely used anticoagulant that has been available for more than half a century. After receiving approval for its drug, Pradaxa to prevent stroke in patients with cardiac arrhythmias, Boehringer Ingelheim now has a head start in this highly lucrative field.

Emergency Contraception-HRA Pharma’s drug ella, was approved by the FDA last summer. It blocks pregnancy up to five days after sexual intercourse, a full-day longer than other drugs on the market. The drug is now marketed in the US by Watson Pharmaceuticals.

In Limbo
Stroke Prevention-The FDA asked AstraZeneca for more information from a generally positive study of the anticoagulant, Brilinta assuring a longer glide path to market for Boehringer’s entry into this space (see above). (more…)


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Predicting the Impact of a Tax on Sugary Drinks

January 12th, 2011 | 1 Comment | Source: Archives Int. Medicine, BurrillReport, NPR

Several studies have confirmed the link between excessive intake of sugary drinks and obesity, especially in kids and teenagers. Other studies have shown that steep taxes on cigarettes can cut smoking rates. So it’s plausible that a steep tax on sugary drinks could cut their consumption as well.

A dozen states have followed this logic; they already impose taxes on sugar-laced drinks. But how big an impact can we expect from a national tax on such beverages?

Not that much, according to a new study by Eric Finkelstein and colleagues at Duke. What is more, the impact would end-up being localized to middle-class Americans, leaving the rich and poor relatively untouched.

To reach these conclusions, Finkelstein’s group looked at the association between beverage prices, energy intake, and body weight using a multivariate regression model. Their data set was derived from the 2006 Nielsen Homescan panel, in which a nationally-representative sample of US households  uploaded their store-bought food and beverage purchases into a database every week for one year.
The scientists found that a 20% and 40% tax on all sugary drinks would reduce calorie intake by a bunion-sized 7 and 12 calories per day, respectively. This would result in an average weight loss of 0.7 and 1.2 pounds per person per year, respectively. Interestingly however, nearly all of this impact accrued to those in the middle-income tax bracket.

The scientists also calculated that the 40% tax would generate about $2.5 billion per year in tax revenue, and that the lion’s share of this money would come from high-income households. They suggested that extending the tax to restaurants and vending machines would increase the take, but only modestly.

“Although small, given the rising trend in obesity rates, especially among youth, any strategy that shows even modest weight loss should be considered,” Finkelstein commented.

But Susan Neely, president of the American Beverage Association didn’t think much of the idea. “Taxes are not going to teach our children how to have a healthy lifestyle,” she has said.

Regardless, public support for a soda tax would be weak, at best. Last April, a survey conducted by NPR and Thomson Reuters revealed that 51% of Americans were moderately or strongly opposed to such a tax. Only about a third liked the idea. Responses were not affected by income or age, although party affiliation did: 70% of Republicans were against the sugar tax, whereas only about 55% of Democrats were against the idea.

Finkelstein’s write-up appears in the Archives of Internal Medicine.



Playing Tetris Cuts Flashbacks in PTSD

December 22nd, 2010 | 2 Comments | Source: BurrillReport, PLoS Medicine

Flashbacks are vivid, recurring, intrusive and unwanted mental images of a past traumatic experience. They are a sine qua non of Post-Traumatic Stress Disorder (PTSD). Although drugs and cognitive/behavioral interventions are available to treat PTSD, clinicians would prefer to utilize some sort of early intervention to prevent flashbacks from developing in the first place. 

Well, researchers at Oxford University appear to have found one. Remarkably all it takes is playing Tetris. Yes, Tetris!

The team responsible for the discovery was led by Emily Holmes. The write-up appears in the November issue of PLoS One. Holmes and colleagues had reasoned that the human brain has a limited capacity to process memories, and that memory consolidation following a traumatic experience is typically complete within 6 hours after the event. Holmes’ team also knew that playing Tetris involved the same kind of mental processing as that involved with flashback formation. So they figured if they had people play Tetris during that 6-hour window after the traumatic event, it might interfere with memory consolidation of the traumatic experience. That in turn, would reduce or eliminate the flashbacks.

The idea worked like a charm.

The Experiment: Holmes’ team had 40 subjects watch a 12-minute film depicting traumatic scenes of injury and death, and then randomized the group to either play the classic video game after the movie ended, or to sit there and do nothing. The groups were similar with respect to age, gender and pre-existing psychological make-up.

Subjects in both groups kept track of any flashbacks for a week using a diary. Then, they underwent a formal clinical assessment and various memory tests.

The scientists observed that Tetris appeared to act like a “cognitive vaccine.” Subjects who played the game after watching the movie had fewer flashbacks during follow-up. Amazingly, the Tetris players’ memory of the movie and the associated trauma was the same as the control group. They just had fewer flashbacks.

Extra Credit: To elucidate the mechanisms behind Tetris’ beneficial impact, Holmes’ group performed a follow-up study comparing Tetris with Pub Quiz in a head-to-head match-up. The latter computer game has different mental processing demands than Tetris, and it turned out to actually increase the frequency of flashbacks and other PTSD symptoms.

The authors hypothesized that discussions and debriefing sessions, which constitute the traditional therapeutic intervention in the immediate (that is, within 6 hours) aftermath of a traumatic experience may actually do more harm than good. That’s because these interventions may actually enhance memory consolidation of the traumatic event.



Scientific Fraud and the Repeat Offender

December 14th, 2010 | No Comments | Source: BurrillReport, J. Medical Ethics

US scientists are more likely than their counterparts in other countries to publish research studies containing fabricated or falsified data, according to a study by R. Grant Steen. And scientists who perpetrate fraudulent research like this are more likely than most to repeat the egregious behavior.

To reach these conclusions, Steen reviewed all 788 English language research papers that had been retracted from the PubMed database during the past decade. Compiling relevant information from the associated retraction notices, Steen classified the causes for retraction as being due to either fraud or an honest procedural mistake.

Steen found that about 75% of the retractions resulted from procedural error, and 25% were caused by fraud. Remarkably, papers retracted because of fraud were published in journals with a higher “impact factor,” that is, journals containing articles that are cited more frequently by other scientists.

Steen also found that articles retracted because of fraud tended to have more co-authors and to take longer to retract than the ones retracted because of procedural mistakes.

Of the 788 retracted papers, fully one-third featured a US-based scientist as the first author, and one-third of these were retracted because of fraud. Asian nations accounted for an additional 30% of the retracted papers, although only one-fourth of them were retracted because of fraud. In fact, the US was the only country in which significantly more papers were retracted because of fraud than procedural errors.

A stunning 53% of all fraudulent papers had been penned by a “repeat offender,” a first author that had been associated with a retracted paper in the past. In contrast, only 18% of the papers retracted because of mistakes featured first authors that had been previously involved with a retracted paper.

“The duplicity of some authors is cause for concern,” Steen wrote. The results of this study, “suggest that papers retracted because of data fabrication or falsification represent a calculated effort to deceive. It is inferred that such behavior is neither naïve, feckless nor inadvertent.”



Obesity on the Rise in Developing Nations

December 13th, 2010 | 1 Comment | Source: BurrillReport, Lancet

Emerging economies must act immediately to halt rising obesity rates before the epidemic becomes as severe as it is in first-world countries, according to new report by the Organization for Economic Cooperation and Development.

The OECD report was published in the Lancet. It characterizes the prevalence of obesity in Brazil, China, India, Mexico, Russia and South Africa. Obesity rates were found to vary dramatically across these 6 countries. In Mexico, a stunning 70% of adults were reported to be overweight or obese. Nearly half of all Brazilians, Russians and South Africans fell into these categories. China and India had a lower prevalence of overweight and obesity, but were moving rapidly in the wrong direction, according to the OECD.
Developing nations don’t have enough resources to handle the health consequences of obesity, which include an increased risk of cardiac disease, stroke, cancer, diabetes, arthritis and disability from all causes.
As a result, the OECD has implored these countries to head-off the worsening crisis now, “as part of wider comprehensive health prevention strategies, rather than (waiting) until the costs of treating obesity-related illness (becomes) much more expensive.”
The OECD estimates that the per capita cost per year of a national campaign to prevent obesity and other health threats like cigarette smoking, excessive alcohol intake and high blood pressure would be less than $2 per-person in China and India, about $3 in Brazil, and $4 in Mexico, Russia and South Africa.
The campaign would include a mass media blitz designed to promote healthy lifestyles, taxes and subsidies aimed at improving diet, improved federal regulation of food labeling, and restrictions on advertising for fast food. It would add 1 million years of life in good health in India alone, and 4 million years in China during the next 2 decades. It would pay for itself immediately via reduced health care costs in 3 of the 6 countries surveyed, and would become cost-effective in the other three within 15 years.
“A multiple intervention strategy would achieve substantially larger health gains than individual programs, with better cost-effectiveness,” OECD health policy analyst and lead author Michele Cecchini said in a press release.



Gene Therapy for Depression

November 26th, 2010 | 1 Comment | Source: BurrillReport, Science Translational Med.

Gene therapy involves replacing or altering a small part of DNA whose abnormal expression causes a disease. The new therapeutic technique has shown promise for the treatment of cystic fibrosis, hemophilia and muscular dystrophy. Now, according to scientists at Weill Cornell Medical Center, perhaps depression should be added to this list as well.

In mice that is. Perhaps someday gene therapy can be used to treat humans as well.

That’s the suggestion made by Michael Kaplitt and colleagues in their write-up summarizing the results of their recent experiments which appears in Science Translational Medicine.

Kaplitt’s team knew that abnormalities in a particular region of the brain-the nucleus accumbens-were associated with depression in humans and behaviors akin to depression in mice (specifically, murine responses to rewards and pleasurable experiences). They knew that the problem in the nucleus accumbens had to do with abnormalities in the way the neurotransmitter serotonin impacted chemical pathways that mediated mood, appetite and sleep patterns. And they knew that most antidepressant drugs acted to regulate serotonin metabolism in the brain.

Kaplitt’s group went from there to isolate the problem with serotonin metabolism in the nucleus accumbens of “depressed” mice. It turned out to be the lack of a single protein, known as p11, which normally serves to transport serotonin receptors to the surface of nerve cells. When p11 was missing or didn’t work properly, nerve cells could produce adequate amounts of serotonin receptors, but the receptors never made it to the surface of the nerve cell membrane where they could bind serotonin and thus trigger normal behavioral responses.

Kaplitt’s team then used somatic gene transfer (that is, “gene therapy”) to replace the gene responsible for producing the defective p11 protein in the nucleus accumbens of their depressed mice. They subsequently observed that the depressive symptoms disappeared.

“We potentially have a novel therapy to target what we now believe is one root cause of human depression,” Kaplitt told BurrillReport. Kaplitt’s team hopes to launch a clinical trial of gene therapy in humans with depression sometime soon.



Why Autism is More Common in Boys

November 15th, 2010 | 1 Comment | Source: BurrillReport

Toronto-based scientists have found that boys with a specific DNA mutation on their X-chromosomes are at high risk of developing Autism Spectrum Disorder (ASD).

To reach these conclusions, John Vincent and colleagues at the Centre for Addiction and Mental Health compared the gene sequences of 2,000 people with ASD with a control group that had no behavioral or intellectual limitations.

The scientists found that about 1% of boys with ASD also had mutations in a gene known as PTCHD1, which is located on the X-chromosome. The scientists did not find these mutations in boys who were in the control group.

“We believe the PTCHD1 gene has a role in a neurobiological pathway that delivers information to cells during brain development–this mutation may disrupt crucial developmental processes, contributing to the onset of autism,” Vincent told BurrillReport. “Our discovery will facilitate early detection (and) increase the likelihood of successful interventions.”

ASD is a neurological condition associated with abnormal social interaction and communication, unusual behaviors, and frequently, diminished intelligence. It affects about one in 240 girls and one in 70 boys. The causes of ASD remain unknown, though scientists have long suspected that genetic factors play a role.

Boys inherit an X-chromosome from their mothers and a Y-chromosome from their fathers. If a boy’s lone X-chromosome lacks a normally functioning PTCHD1 gene, he is at risk for ASD or some other intellectual disability, the scientists explained. Girls inherit an X-chromosome from their mothers and fathers, so the effects of a PTCHD1 gene defect in one X-chromosome are masked by the normally functioning gene on the other X-chromosome. These girls will not develop ASD, but their male offspring are at risk.

The study appears in Science Translational Medicine. 



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