At the American Heart Association’s (AHA) annual scientific sessions held November 11 in New Orleans, scientists revealed that obese kids and teenagers have carotid artery walls similar to those of an individual nearly three decades older.

Scientists who have been researching the effects of obesity among kids and adolescents have deemed the effects detrimental, according to authors of a study conducted by the Stress Testing Laboratory at Ochsner Heart and Vascular Institute in New Orleans. Additionally, an associate professor of internal medicine and an assistant professor of pediatrics at the Texas AM Health Science Center College of Medicine found during the study that the risk factor of obesity leading to “premature cardiovascular disease in youth” was extremely high and that obesity was more of a risk factor for cardiovascular disease among young males than smoking.
Defining Obesity In America

According to the American Academy of Child and Adolescent Psychiatry (AACAP), obesity among children and adults is a recently growing epidemic with “between 16 and 33 percent of children and adolescents” considered obese.

The AACAP defines child obesity as a child whose “weight is at least 10 percent higher than what’s suggested for the height and body type.” There are lots of factors that might lead to obesity among a child or adolescent in America including the following, as described by the AACAP:

* poor eating habits

* overeating or binging

* lack of exercise

* family history, genetics

* medical illnesses including endocrine or neurological issues

* medications such as psychiatric medications or steroids

* stressful life events or changes, cultural factors including divorces, parent separations, moves, deaths, or child abuse

* family and peer issues

* low self-esteem

* depression, emotional or behavioral problems

The AACAP reported that “a child who is obese between the ages of 10 and 13 has an 80 percent change of becoming an obese adult.” Additionally, there are several severe risk factors and complications that can be the result of child obesity including:

* increased risk of cardiovascular or heart disease

* difficulties breathing

* high blood pressure

* difficulties sleeping

* diabetes

Diabetes and Treatments

In March 2002 the New England Journal of Medicine reported that approximately “22 million kids under five years of age were overweight.” Additionally, the Medical COllege of Wisconsin reported that “childhood obesity is a major health problem and a growing wave of obesity among kids is helping fuel a parallel epidemic in the rate of diabetes.”

Because diabetes, especially type 2 diabetes, is a growing complication of childhood obesity it becomes imperative that a child be cared for and diagnosed properly by a qualified physician who can prescribe a diet and exercise plan as well as potential medications to aid in a child’s glucose and insulin regulation if onset of such a condition occurs.

However, it is important for parents to note that type 2 diabetes medications might cause severe side effects that could harm a child. For example, the drug Avandia, from GlaxoSmithKline is a type 2 diabetes drug that was recently linked to the development of heart disease and heart failure as well as early onset osteoporosis among patients.

If an individual has been negatively impacted by the Avandia side effects they may be advised to contact a pharmaceutical attorney who can offer a free legal consultation as the development of an Avandia class action lawsuit. Developing such litigation may cause monetary compensation to be awarded to victims of the Avandia risks.

About the Author

LegalView (http://www.LegalView.com ) offers a plethora of legal topics for individuals in need, ranging from information on Avandia (http://avandia.legalview.com ) to the latest on the Ketek dangers to the best way to obtain a mesothelioma attorney.

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Researchers at the University of Alberta (UA) recently discovered an increased risk of developing type 2 diabetes among individuals with depression. A study, published in Diabetes Research and Clinical Practice, found that patients who have been diagnosed with depression may have a 30 percent increased risk for developing diabetes.

Lauren Brown, the lead author of the study, researched the history of 2,400 individuals who had been diagnosed with depression. Brown looked at the various types of treatments that these individuals were taking and discovered that patients receiving tricyclic antidepressants (TCAs), which are an older form of antidepressant treatments, combined with the newer brand of antidepressants known as selective serotonin re-uptake inhibitors (SSRIs) had double the risk of developing type 2 diabetes.

While the study needs further research to better understand the relationship between antidepressants and developing type 2 diabetes, it is important that patients of depression as well as diabetes receive educational information on both conditions and the link to better assess and treat their potential illnesses, according to the study.

What are TCAs and SSRIs?

Tricyclic antidepressants are used to treat abnormalities involving neurotransmitters serotonin, norepinephrine and dopamine, according to the Mayo Clinic. The TCAs “inhibit the reabsorption of serotonin and norepinephrin” and block certain cell receptors. TCAs were first introduced to the market in the 1960s and remained a top treatment of depression among patients through the 1980s until the development of SSRIs. Common side effects that have been associated with TCAs include:

* constipation, urinary retention

* drowsiness and dizziness

* dry mouth

* blurred vision

* impaired sexual function

* increased heart rate

* headache

* increased appetite, weight gain

* weakness

* low blood pressure or increased heart rate

* nausea

According to the Mayo Clinic, patients of TCAs might have issues with their blood sugar levels, but the drug has never been linked directly to having caused diabetes.

Health Insite, an initiative by the Australian government, describes SSRIs as a group of antidepressants that activate nerve cells within the brain to regulate serotonin levels. According to Harvard Medical School, SSRI side effects may include:

* insomnia

* rashes

* headaches

* joint and muscle pain

* diarrhea, nausea or upset stomach

* potential risk of stomach or uterine bleeding

* diminished sexual interest/desire

* impaired sexual function

* suicide and increased suicidal thinking

Patients are advised to discuss any sudden change in moods, and, with the increased risk of developing diabetes, patients taking both SSRIs and TCAs should consult their doctor if weight gain or loss begins to affect moods.

How is Type 2 Diabetes Diagnosed?

Individuals who feel they may suffer from type 2 diabetes will likely receive one or all of the following tests, according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDD):

* fasting plasma glucose test

* oral glucose tolerance test

* random plasma glucose test

It is important to know the signs and symptoms of diabetes in order to receive diagnosis and treatment of the condition immediately, as the condition can worsen if left untreated. The American Diabetes Association (ADA) reported the following diabetes symptoms for individuals to watch for:

* frequent urination

* extreme hunger

* blurry vision

* irritability

* extreme thirst

* increased fatigue

* unexplained weight loss

It is extremely important for patients suffering from depression to contact a medical professional if they feel they might suffer from type 2 diabetes as well. If diagnosed with type 2 diabetes, it is important to become aware of the potential risks involved with consuming type 2 diabetes medications such as Avandia from GlaxoSmithKline, is an anti-diabetic medication that was linked to early on-set osteoporosis as well as heart failure among type 2 diabetes patients.

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For more information on Avandia visit http://www.avandia-legal-help.com/. Additionally, individuals can learn about other legal topics ranging from developing Nephrogenic Systemic Fibrosis side effects or the latest on mesothelioma treatments, all by visiting http://www.LegalView.com/.

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Swiss researchers recently concluded that Avandia, a type 2 diabetes drug, nearly doubles the chances of osteoporosis and bone fracture among patients who take the drug and is increased for patients taking the drug for more than a year. The results of the study come on heels of controversy surrounding the drug’s link to increased heart disease and various studies warning of potential risks related to bone degradation.

The type 2 diabetes drug was introduced to the market in 1999 from GlaxoSmithKline, and has been reportedly prescribed to nearly 3.5 million Americans suffering from the disease. Avandia was once considered one of the most popular treatments until results of several clinical trials reported in the news in 2007 determined a strong connection of the drug to cardiomyopathy and cardiovascular disease. One study, published by the Cleveland Clinic, found a 43 percent increase for patients developing these various heart diseases. Dr. John Buse, an expert on diabetes, has openly said that Avandia might have been responsible for approximately 83,000 preventable myocardial infarctions over the last few years.

Additional studies then began to surface linking the drug to an increased risk of osteoporosis, although many of the studies did not have definitive proof of the connection until the recent Swiss study was published. The Swiss study determined patients on Avandia and Actos, which is also part of the Avandia class of drugs known as thiazolidinediones, doubled and, in some cases, tripled the odds of non-spine fractures among patients, according to news reports. For patients who took the drug for 12 to 18 months, this risk increased, and for those on the drug longer than two years were found to be at the highest risk of bone fracture and osteoporosis.

Osteoporosis is a disease characterized by loss of bone density and leads to abnormally porous bones, thus increasing the fragility of bones and an increase of fractures and breaks. A bone diseased with osteoporosis will have a density similar to that of a sponge, whereas healthy bones have a brick-consistent density level. Bones are made up of collagen, calcium and protein to ensure strength. Avandia was found to inhibit the development of osteoclasts and osteoblasts, which are cells that induce the redevelopment of healthy bone over time. It has been suggested that almost 18 million Americans are at risk for osteoporosis and those taking Avandia increase that risk as well as the odds for early onset osteoporosis.

The Swiss researchers used medical records of over 1,000 diabetic patients who were diagnosed with bone fractures between the years of 1994 and 2005. The medical records included diagnosis of fractures for these patients from British physicians, and the research was compared to a control group of diabetics that did were not diagnosed with bone fractures during that time. Since these reports began to surface the manufacturer has seen a noticeable decline in sales. Most recently, the U.S. Food and Drug Administration (FDA) issued a warning letter to GlaxoSmithKline after a routine inspection turned up information being withheld by the company to the FDA on Avandia.

Even though, the FDA has yet to address the new research on the osteoporosis and bone fracture risk of Avandia. In fact, the FDA has only responded to the controversial heart disease link by placing a black box warning on Avandia prescriptions, which some health experts consider to be a mild slap on the wrist considering the severe safety issues associated with the drug and many of these individuals are advocating removal of the drug from the market. The black box warning is the strongest label given by the FDA and warns of significant risk and the potential for life-threatening risks associated with taking a drug.

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Visit http://avandia.legalview.com to find more details on this and other studies surrounding the Avandia risks. Or, peruse LegalView’s homepage at http://www.LegalView.com for information on mesothelioma litigation and jury verdicts, which remains a deadly cancer with little successful treatments.

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We have posted quite a lot about what came to be called the “Avandia” case. This started with the publication in the New England Journal of Medicineby Nissen and Wolski of a meta-analysis focused on cardiac adverse effects of rosiglitazone (Avandia, by GlaxoSmithKline) (see post here). One of the most important aspects of this case, in my humble opinion, which we posted about here, but has not been widely discussed, is that it is a case of the suppression of clinical research.

As we posted last year, the Nissen and Wolski meta-analysis [Nissen SE, Wolski K. Effects of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356, on the internet here] was to be the first published article to combine data from all relevant clinical trials of rosiglitazone completed to date. Although two major trials of Avandia had been published, its manufacturer, GlaxoSmithKline, had performed many other smaller trials of the drug, most of which have not been published to date. They did eventually appear on a web-site run by GSK. However, this web-site was relatively obscure, and it wasn’t created voluntarily, but in response to a settlement of legal action that alleged GSK had suppressed clinical research about its antidepresant paroxetine (Paxil). (See Steinbrook R. Registration of clinical trials - voluntary of mandatory. N Engl J Med 2004; 351: 1820-1822, link here and our post here).

Nissen and Wolski found it, compiled the results of trials on Avandia, and combined their results with those of the few published trials in their meta-analysis.It is to the credit of Nissen and Wolski to figure out how to do this. It isn’t to the credit of GSK that they sat on the data from these trials, only put it on this web-site when compelled to do so, didn’t make any effort to publicize the web-site, and did not publish a meta-analysis done by company scientists that showed qualitatively similar results to that done by Nissen and Wolski (see post here).

Now, as first reported on the PharmaLot and WSJ Health Care blogs, the US Food and Drug Administration (FDA) issued a warning letter to GSK about its suppression of multiple studies about Avandia. (Link here courtesy PharmaLot.)

In particular, the letter asserted,

The inspection found that your firm failed to report multiple postmarketing studies involving Avandia in mandatory Periodic and/or NDA Annual Reports.

The letter listed numerous studies which GSK failed to report

Furthermore, the letter stated,

Your firm lacked appropriate knowledge of the studies associated with Avandia, resulting in the reporting deficiencies noted. Absent a clear explanation of the extent and cause of these deficiencies and an sufficient plan to correct them, we are concerned that similar deficiences in the postmarket reporting for your firms other FDA-approved drugs may exist.

Thus,

The specific violations noted in this letter are serious and might be symptomatic of underlying postmarketing safety reporting failures.

So I guess I was not just whistling Dixie when I discussed the Avandia case in terms of suppression of research.

Let’s just review why it’s bad to suppress research.

First, suppression of research can distort medical decision making, leading to poor decisions for particular patients and thus bad outcomes for some of them. Patients and doctors ideally should base decisions on the best available clinical evidence relevant to the patients’ problems. Suppressing evidence that’s unfavorable to particular companies’ products might lead to use of that product in situations in which it may do no good, or in situations in which it is more apt to produce adverse effects than some substitute. Furthermore, unreasonably delaying or attempting to suppress publication of results of clinical research betrays the trust of the research subjects. Research subjects usually volunteer with the understanding that results of research done on them would be published. Such results could only have been obtained because of their willingness to participate.

At least more cases of attempted suppression of research are now getting the bad publicity they deserve. No we need to mend the problem An obvious solution would be decreasing or abolishing control of clinical research by those with vested interests in the research coming out a certain way.

[Source : Health Care Renewal]

We’ve posted frequently about the controversy about rosiglitazone (Avandia, by GlaxoSmithKline). Some of the distressing aspects of the case were various efforts made to keep information and opinions unfavorable to Avandia away from doctors, patients, and the public, including efforts involving obfuscation, deception, and intimidation. (For example, see this post about the “spinning” of Avandia and the ridiculing of Avandia critics, and this post about attempts to silence an early Avandia critic.)

So it is ironic that the latest Avandia controversy is about the premature release of a manuscript submitted for publication.

Recall how the story began, with the publication in the New England Journal of Medicine by Nissen and Wolski of a meta-analysis focused on cardiac adverse effects of rosiglitazone (Avandia, by GlaxoSmithKline) (see post here). The main achievement of the Nissen and Wolski meta-analysis [Nissen SE, Wolski K. Effects of rosiglitazone on the danger of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356, online here] was to be the first published article to combine data from all relevant clinical trials of rosiglitazone completed to date. Even though two major trials of Avandia had been published, its manufacturer, GlaxoSmithKline, had performed many other smaller trials of the drug, most of which haven’t been published to date. They did eventually appear on a web-site run by GSK. However, this web-site was relatively obscure, and it was not created voluntarily, but in response to a settlement of legal action that alleged GSK had suppressed clinical research about its antidepresant paroxetine (Paxil). (See Steinbrook R. Registration of clinical trials - voluntary of mandatory. N Engl J Med 2004; 351: 1820-1822, link here and our post here). Nissen and Wolski found it, compiled the results of trials on Avandia, and combined their results with those of the few published trials in their meta-analysis.

Now it turns out one of the NEJM peer reviewers of the Nissen and Wolski manuscript leaked it to GSK well before the manuscript was published. From the News section of Nature,

17 days earlier [before the article was published], the reviewer, diabetes researcher Steven Haffner of the University of Texas Health Science Center at San Antonio, had faxed his copy of the article to Alexander Cobitz, a GSK employee whom Haffner knew from working on an earlier clinical trial of the drug.

This was a serious breach of the reviewers’ code of conduct. Having reviewed many articles for many medical journals, (but not the NEJM), I have the ability to say with conviction that reviewers are forbidden from releasing unpublished manuscripts to anyone, with only one major exception. Reviewers can seek reviewing help from a colleague, as long as this is disclosed to the journal, and the colleague does not further release the manuscript.

As pointed out by an article by Stephanie Saul in the New York Times,

Under The New England Journal’s rules, reviewers are prohibited from disclosing an article’s contents before publication, as a way of protecting the exclusivity of the journal’s material and protecting the intellectual property of scientists who submit articles.

Besides violating The New England Journal’s rules, disclosing a pending article would also be considered a breach of professional ethics, according to Dr. Jerry Avorn, a professor of medicine at Harvard Medical School. Dr. Avorn said that he was not familiar with the specific allegations against Dr. Haffner.

So why did Dr Haffner do it? His explanation of why he sent the manuscript was at best incoherent.

‘Why I sent it is a mystery,’ Haffner told Nature . ‘I don’t really understand it. I wasn’t feeling well. It was bad judgement.’ Haffner says that Cobitz didn’t ask to see the draft and was ‘probably a bystander’.

According to a report in theHeart.org, a GSK spokesperson rationalized Haffner’s conduct thus,

Haffner, who consulted for GSK on Avandia, had concerns and questions regarding the methodology of the analysis and sent the article to GSK for advice from company statisticians.

This begs the question of why he didn’t simply note in his review his lack of expertise on the relevant statistical issues, or seek help from a statistician at the University of Texas.

So perhaps we should seek other explanations. Dr Haffner, it turned out, had a number of financial ties to GSK. As reported in Nature.

Haffner had earlier served on the steering committee of a GSK-sponsored clinical trial of Avandia. He states that he has given many talks for the company, although he declined to state how much he had earned from them. ‘I have got a considerable amount of money. I didn’t do it to raise my income or anything like that,’ he says.

Furthermore, in the NY Times article,

Dr. Haffner, who had been involved in a clinical study that found Avandia worked superior at controlling blood sugar than two other treatments, was quoted last year in the on the internet medical publication TheHeart.org criticizing the publication of Dr. Nissen’s study and of editorials that supported it in two other journals.

‘The three major medical journals are becoming more like British tabloid newspapers. All they lack is a bare-chested woman on Page 3,’ Dr. Haffner was quoted as saying.

In fact, Dr Haffner was one of the co-investigators for the ADOPT study, which compared rosiglitazone to metformin or glyburide, and was sponsored by GSK. [Kahn SE, Haffner SM, Heise MA et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med 2006; 355: 2427-43. See link here.] In that article, Haffner disclosed,

Dr. Haffner reports receiving consulting fees from AstraZeneca and Takeda; consulting fees and allow support from Novartis and Pfizer; allow support and consulting and lecture fees from GlaxoSmithKline; consulting and lecture fees from Merck; and lecture fees from Sanofi-Aventis.

Furthermore, an article in the Philadelphia Inquirer noted,

Haffner is a national expert in diabetes. His university Web site calls him ‘one of the highest-funded investigators, in terms of [National Institutes of Health] funding, in Health Science Center history.’

And we know that in this age of “greed is good” as the reigning philosophy in medical schools and academic medical centers, the biggest “tax-payers” like Haffner can do no wrong in the eyes of the administrators of these institutions.

So the Avandia story gets more complex, involving more people with more conflicts of interest, and not only suppression of research, but the breach of confidentiality of an unpublished manuscript submitted for publication.

Dr Haffner’s almost nonsensical explanation of why we went running to his fax machine to send the confidential manuscript to his part-time GSK employers is another reminder of the confused reasoning often displayed by people with conflicts of interest, even full professors of medicine who are supposed to be national authorities. As noted before, “people who have conflicts of interest often find giving clear advice (or thoughts) particularly difficult.” Apparently becoming a consultant for a pharmaceutical company makes one susceptible to faxing confidential manuscripts in a fugue state, something like the sleep-driving pheonomenon reportedly caused by sleep medications like Ambien.

This latest development in the Avandia case is yet another argument that physicians should not only not accept pens, coffee mugs, and free pizzas from companies trying to sell their medical and health care products and services, but that academic physicians should shun all financial ties to these companies. (A physician who wants to work for a pharmaceutical, biotechnology, or device company should do so full-time, or not at all, in my humble opinion.)

Otherwise, prepare to appear on the national news blinking like a deer in the headlights, saying “Why I did it is a mystery.”

ADDENDUM (31 January, 2008) - See also this post on the Clinical Psychology and Psychiatry Blog.

[Source : Health Care Renewal]