Archive for July, 2009

Asthma, Eczema Link

July 31st, 2009 | No Comments | Source: Economist, PLoS Medicine

Asthma is common in first world nations, unheard of in the developing world and rising quickly in countries making the transition.

gimmethesteroidsMany theories have been posited to explain this association. They range from the idea that clean living somehow revs-up the immune system to a belief that swimming pool chemicals bring on the allergy-mediated condition.

The common denominator is that environmentally mediated phenomena associated with economic development are directly triggering asthma.

Shadmehr Demehri and colleagues at Washington University in St. Louis have postulated an indirect link, in which environmental factors trigger eczema, a benign though annoying skin condition, and the distressed skin cells create chemical signals that in turn trigger asthma. 

Eczema is also linked to economic development. Nearly 17% of US children have it, and nearly 70% of children with eczema develop asthma, even though the prevalence of the letter condition in the general population is only 4-8%.

Demehri’s team believes the culprit is thymic stromal lymphopoietin (TSLP), an immune-stimulating molecule released by skin cells when they are damaged, as by eczema. TSLP, they theorize, causes lung tissue to over-react to allergens, which leads to asthma.

The team wrote-up the results of 3 experiments in the Public Library of Science Biology that provide support for its hypothesis.

First, the scientists showed that mice genetically engineered to develop eczema were prone to develop asthma. Then they deleted the gene coding for the TSLP receptor in the bronchial tissue of such mice and voila, the new editions did not develop asthma.

In the third step, the scientists created mice that over-produced TSLP in the absence of skin problems. These mice wheezed up the wazoo.

Case closed, at least in mice. Eczema is easily treated, by the way, with low-dose topical steroids.



Merck CHF Drug a Bust

July 31st, 2009 | No Comments | Source: Wall Street Journal

New Jersey-based drug giant Merck & Co. announced last week it will not seek FDA approval this year for a heart-failure drug after preliminary results from a late-stage study showed the stuff didn’t meet efficacy targets.

merckIn 2007, Merck acquired the drug, rolofylline as part of its $366 million buy-out of NovaCardia. 

It was the latest in a series of hits to the company’s  late-stage drug pipeline which was described by Sanford Bernstein analyst Timothy Anderson as “uninspiring” in a memo to investors after the announcement.

Three months ago, Merck said it was postponing near-term plans to seek approval for its migraine fix, telcagepant, after safety concerns surfaced in a mid-stage study. In 2008, the FDA asked Merck to wait until a large trial concluded in 2013 before seeking approval for Cordaptive, a cholesterol-buster.

In addition, Merck recently shelved its early-stage obesity drug, taranabant due to a lousy side effect profile.

youcan'tbeseriousMerck spokesperson Ronald Rogers scoffed at criticisms of his company’s pipeline.

In fact it has a “strong track record of bringing new products to market,” he told the Wall Street Journal, citing the diabetes drug Januvia, the HIV-fighter Isentress, and Gardasil and Zostavax, the vaccines for cervical cancer and shingles, respectively.

thePloughThe recent setbacks have highlighted the importance of Merck’s plan to acquire the Plough for $41 billion, a deal that should close in Q4. Both companies are fired up about 2 potential blockbuster drugs in the Plough’s pipeline—the clot-buster TRA and the arthritis drug golimumab (aka Son of Remicade).

Merck’s asthma drug, Singulair, accounts for 18% of the company’s revenues. It loses patent protection 3 years from now.



Who Says Alcohol is Good for You?

July 30th, 2009 | No Comments | Source: NY Times

In 1924, Johns Hopkins biologist Raymond Pearl published a U-shaped graph showing high death rates for heavy drinkers and abstainers, and lower death rates among moderate drinkers.

KonTikiSince then, hundreds of observational studies have confirmed the association and suggested reasons for it.

The juice is purported to reduce coronary disease, for example, because it increases HDL cholesterol and has anti-clotting effects.

Moderate alcohol consumption is also associated with slower cognitive decline in the mildly impaired elderly and improved bone mineral density in elderly women. In addition, light drinkers tend not to develop diabetes, and that those with diabetes tend not to develop coronary disease.

Could all this research be wrong?

“The moderate drinkers tend to do everything right — they exercise, they don’t smoke, they eat right and they drink moderately,” affirmed Kaye Fillmore, a retired sociologist from UCSF. “It’s hard to disentangle all of that, and that’s a problem.”

And alcohol consumption, even at moderate levels, has a dark side. It has been linked to multiple cancers, fatal accidents, neuropathies and of course, liver disease.

That’s why health guidelines on the matter walk a fine line. The American Heart Association warns that people should not start drinking to protect themselves from cardiac disease. And the US dietary guidelines hedge goes something like this: “alcohol may have beneficial effects when consumed in moderation.”

A confounding factor is that at least some studies showing a beneficial association were funded by the alcohol industry.

A few years ago for example, BU physician Curtis Ellison hosted a conference on the subject and published a summary one year later. The summary indicated the attendees had reached a “consensus” that moderate drinking “has predominantly beneficial effects on health.”

The meeting, as well as much of Ellison’s work, was partially financed by the industry, according to the New York Times. And the summary itself was co-authored by Marjana Martinic, a senior VP for the International Center for Alcohol Policies, an industry-supported group. Yeesh!



FDA Cracks Down on Swine Flu Hoaxes

July 30th, 2009 | No Comments | Source: FDA

The Food and Drug Administration is mad as hell about illegal products marketed over the Internet claiming to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 (Swine) flu virus.

And it’s not going to take it anymore.

The FDA has warned consumers to stay away from Swine flu products that it has not approved, cleared, or authorized, and beginning in May, it warned more than 50 offending Web site operators to cut it out (see full list here).

Approximately 66% of them did so.

That wasn’t good enough for FDA Commissioner Margaret Hamburg. In a press release last week she said “we are committed to pursuing those who attempt to take advantage of a public health emergency by promoting and marketing unapproved, or unauthorized products. We will (continue) our efforts to protect consumers from these fraudulent, potentially dangerous products.”

The bogus products targeted by the FDA include:
– A shampoo claiming to protect against H1N1,
– A dietary supplement claiming to protect infants and children from H1N1,
– A supplement claiming to cure H1N1 in 4-8 hours,
– A spray claiming to leave a layer of ionic silver on one’s hands that killes the virus
– Several tests claiming to detect the virus, and
– An electronic instrument costing thousands of dollars claiming to use “photobiotic energy” and “deeply penetrating mega-frequency life-force energy waves” to strengthen the immune system and prevent symptoms associated with H1N1.

The scammers were discovered during Internet sweeps undertaken by the several FDA departments and other agencies.

The FDA has threatened to take civil or criminal enforcement action against vendors that fail to comply with the marching orders.



Do ADHD Drugs Kill Kids?

July 29th, 2009 | No Comments | Source: Washington Post

Kids who take Ritalin and Adderall for ADHD are much more likely than their drug-free counterparts to die suddenly, according to scientists at Columbia University.

iainttakinthatStill, the number of deaths in the drug-taking population was small, and limitations in the study prevented the scientists from concluding the popular medicines were causing kids to drop dead.

Physicians have long wondered whether such a link could exist because the drugs are stimulants: they increase heart rate and blood pressure and occasionally precipitate abnormal heart rhythms.

About 2.5 million children take these drugs in the US.

“This study reports a significant association between sudden unexplained death and the use of stimulant medication, specifically methylphenidate (Ritalin),” wrote the authors. Our findings draw attention to the potential risks of stimulant medications for children and adolescents.”

To reach these conclusions, Madelyn Gould and colleagues undertook a matched case-control study involving 564 US children that died suddenly and inexplicably between 1985 and 1996.

The scientists determined which children were taking the stimulants through interviews with parents and a review of medical records.

While kids taking the stimulant medications had a much higher risk of sudden death, the tragic event occurred in less than 1 in 10,000 kids taking the drugs. And it remained possible that ADHD itself might have increased the risk for sudden death.

For those reasons, FDA officials said it would not be necessary to change the warning labels on the drugs and urged parents to take up any concerns with doctors rather than stopping their kids’ drugs cold turkey.

The new safety concerns regarding ADHD drugs come on the heels of an unsightly public dust-up involving co-authors on a scientific paper that appeared to show the drugs had no beneficial effects in the long term.



IOM and Comparative Effectiveness

July 29th, 2009 | No Comments | Source: Institute of Medicine, Wall Street Journal

This post first appeared on the Practice Fusion Blog.

Last week, the venerable Institute of Medicine released a list of 100 research priorities designed to provide a roadmap for the comparative effectiveness agenda mandated by the Big O’s January Hail Mary otherwise known as ARRA.

dontforgetbackpainAt the top of the list are treatment strategies for common conditions like obesity and back pain and the prevention of falls in hospitalized patients. The list also includes mechanisms by which  medical research findings are disseminated to the bedside and to the public.

The full list is here.

Congress allocated $1.1 billion of its $787 billion stimulus package to comparative effectiveness research, assuming such research can improve the quality of health care, though such an impact would be years away.

This “is a program about improving decisions for patients,” Harold Sox told the Wall Street Journal. Sox co-chaired the IOM committee that established the list.

Sox’ team distilled the final 100 from more than 2,600 suggestions submitted by professional groups, policy experts and the public.

Although the products of medical device and pharmaceutical companies will be the primary focus of the research, the former contributed only 11 suggestions and the latter managed just 17. “For whatever reason, we didn’t get many suggestions from them,” Sox understated.

“Right now, the winners and losers (among the various drugs and devices in extant) are based on which company has the best marketing department, rather than who has the best product,” said University of Pennsylvania professor Brian Strom.

“If we show that in certain drugs, the more expensive one is better than the cheaper one, the answer is use the expensive one,” added Strom. “The focus of comparative effectiveness research is that it leads to better care, not cheaper care.”



Teen Suicide Linked to Family Moves

July 28th, 2009 | No Comments | Source: ABC News, Archives Gen'l Psychiatry

A study of children between the ages of 11 and 17 has revealed that suicide risk increases with the number of changes in residence.

howwillimakefriendsTo reach this conclusion, Ping Qin and colleagues from the University of Aarhus used data from Danish population registries to identify 120,000 children born in Denmark between 1978 and 1995.

Using other sources, they subsequently determined  that 4,160 of these people attempted suicide during adolescence. Seventy-nine completed the act.

The scientists then used logistic regression to demonstrate the increased risk of attempted and completed suicide associated with changes in home address. The more frequently the kids moved, the higher was the suicide risk.

Subjects that moved more than 3 times had twice the risk of suicidal behavior as those that stayed put throughout their early years. Those who moved more than 10 times experienced a four-fold bump in such risk.

The finding was not affected by year of birth, birth order, birthplace, age when the move took place, gender, presence of 2 parents, or parental age at birth.

“It’s understandable that a lot of moves increase people’s risk for suicide,” Nadine Kaslow, the chief psychologist at Emory University told ABC news. “Moving is all about losing things.”

But Kaslow cautioned that moving might be a marker for problems rather than the proximate cause of suicidal behavior. “There could be all sorts of other family stressors that are associated with moves,” she reasoned.

The write-up appears in Archives of General Psychiatry.

“It is always good to involve children in the process, motivating their participation in all decisions, plans and practical work,” wrote the authors.

Kaslow recommended having the children visit their new home and, after the move, their old one. But she added the vast majority of children do adjust. “Some kids are at increased risk, but many…do just fine,” she told ABC News.



Avandia Safety a Matter of Record

July 28th, 2009 | 1 Comment | Source: Lancet, Wall Street Journal

A prospective clinical trial of the diabetes drug Avandia has failed to clear the air regarding the blockbuster’s potential to raise cardiac risk.

wtfGlaxoSmithKline, the drug’s maker had hoped that the so-called Record trial would quell concerns that have dogged Avandia since 2007, when a report suggested it was associated with an increased risk of heart attacks compared with other diabetes drugs.

Avandia’s annual sales fell 55% to $1.29 billion since that report surfaced.

On the surface, the Glaxo-funded trial looked promising. Newcastle University’s Philip Home and colleagues reported in last week’s Lancet that people taking Avandia did not experience increased hospitalization rates or cardiovascular mortality compared with those taking other diabetes drugs.

Home’s position on the matter, as reported by the Wall Street Journal, was that Record provided “a robust assessment of [Avandia’s] cardiovascular safety.”
But in an accompanying editorial, Ravi Retnakaran and Bernard Zinman of Mount Sinai Hospital in Toronto said “definitive conclusions” about the drugs cardiovascular risk “remain elusive” because of the study’s methodological problems.

The cardiovascular event rate observed in Record was lower than expected, they said. That meant it wasn’t possible to reach firm conclusions.

The low event rate might have been caused by the coincident use of cholesterol-lowering statins in the Avandia group, or by the unexpectedly high patient drop-out rate from the study, which may have been prompted by safety concerns about Avandia that arose during the trial.

Roughly 45% of the subjects dropped out of the study before it concluded.

Amid the controversy, David Robbins, a professor of medicine at Kansas found a common denominator everyone could agree with. Avandia certainly did not improve cardiovascular outcomes, he reasoned to the Journal. “What we really want in diabetes is…drugs that are reducing cardiovascular events.”



FDA Warns on Leukotriene Inhibitors

July 27th, 2009 | No Comments | Source: Wall Street Journal

The FDA will update the labels on 3 commercially-available leukotriene inhibitors to reflect post-marketing research findings that the asthma-fighters can precipitate neuropsychiatric events ranging from agitation to suicidal ideation.

playingwithfireLeukotrienes have become popular options for treating moderate to severe asthma.

They are usually used in conjunction with bronchodilators or inhaled steroid medications.

The new warnings will appear on the labels for Merk’s Singulair, AZ’s Accolate and Zyflo, which is made by Cornerstone Therapeutics.

Singulair dominates the category from a sales standpoint. First approved in 1998, the drug is Merck’s top revenue-producer with $4.3 billion in sales last year. The drug has been approved for both children and adults with asthma and for the treatment of certain allergies. The latter 2 are approved for asthma only.

Leukotrienes are produced by the body in response to inflammatory stimuli such as inhaled allergens.

“Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications,” read the posting on the FDA website.

Neuropsychiatric events that have been linked to leukotriene inhibitors include agitation, aggression, anxiousness, depression, hallucinations, dream abnormalities, insomnia, irritability, restlessness, suicidal ideation, suicide and tremor.

Merck released a statement saying it was “confident in the efficacy and safety of Singulair,” while adding it would revise the label as directed by the FDA.

Neuropsychiatric events other than sleep disorders and insomnia “were not commonly observed” in trial data provided by the drug makers, according to the FDA.

The FDA launched an investigation last year after receiving reports of mood and behavior changes in patients taking Singulair. It asked all 3 drug makers for all available post-marketing information, and made the call after completing that review.



Cancer Trials Need More Women

July 27th, 2009 | No Comments | Source: BurrillReport, Cancer

Cancer research trials published in peer-reviewed journals tend to include a disproportionately small number of women, according to a study published in Cancer.

pleasecanyouhelpTo reach this conclusion, Reshma Jagsi and her colleagues at the University of Michigan reviewed 661 prospective studies involving more than a million subjects who had non-gender specific cancers like those of the colon, head and neck, lung, brain and lymphomas.

“In the vast majority of studies we analyzed, fewer women were enrolled than we would expect given the proportion of women diagnosed with the type of cancer being studied,” Jagsi told BurrillReport.

Jagsi added, “we’re seeing it in all cancer types. We know there are biological differences between the sexes, as well as social and cultural differences. Studies need to assess whether there are differences in responses to treatment between women and men.”

The practice flies in the face of the NIH’s Revitalization Act of 1993, which highlighted the need to include women in research studies in numbers sufficient to support gender-specific subgroup analyses.

Government-funded studies did include slightly higher numbers of female participants: 41% of subjects in such trials were women, whereas only 37% of the subjects in non-government-funded studies were women.

The authors suggested several reasons for the discrepancy. For example, scientists tend to avoid including “vulnerable populations,” such as women of childbearing age in their studies. “By protecting them from research, we’re excluding them,” the scientists concluded.

Other barriers are thought to include a lack of information, fear, and a belief that the studies interfere with individual responsibilities including child care.

The authors suggest that among other things, investigators should reimburse participants for transportation and child care expenses incurred during the study.



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