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Vitamin E effective for 'silent' liver disease

From EurekAlert!:

NIH-funded, NEJM study is largest ever to look at nonalcoholic steatohepatitis, an obesity-related condition 

Vitamin E has been shown effective in treating nonalcoholic steatohepatitis (NASH), an obesity-associated chronic liver disease that can lead to cirrhosis, liver cancer, and death. NASH also is related to or a part of type 2 diabetes, lipid disorders and cardiovascular disease.

The often asymptomatic condition affects 2 to 5 percent of Americans, although an additional 10 to 20 percent of the population has fat in their liver, but no inflammation or liver damage, a condition called "fatty liver" that is a precursor to NASH. There is no established treatment.

The government-funded multicenter study was organized by the Nonalcoholic Steatohepatitis Clinical Research Network of the National Institute of Diabetes and Digestive and Kidney Diseases, and is the largest ever placebo-controlled randomized trial of treatment for NASH. Results are published in the April 28 online edition of the New England Journal of Medicine.

"There is an increasing prevalence of nonalcoholic steatohepatitis in this country, something that is directly related to the obesity epidemic," says Dr. Lavine, co-chair of the Network's steering committee and a co-author of the study. "The good news is that this study showed that cheap and readily available vitamin E can help many of those with the condition. We also looked at the drug pioglitazone, which showed some benefits, although not as dramatic as with vitamin E."

Dr. Lavine cautions that there are risks with any therapy, even vitamin E, and all treatment should be done under medical supervision.

After 96 weeks of treatment, vitamin E improved all features of NASH with the exception of the amount of scar tissue in the liver; 43 percent of those treated with vitamin E met the primary endpoint of the trial, which was a composite of the scores for several features of NASH indicative of disease activity, compared with only 19 percent of those who received a placebo.

Dr. Lavine joined NewYork-Presbyterian/Columbia from the University of California San Diego in February and brought his NIH grant for the study of fatty liver to NewYork-Presbyterian/Columbia. He is currently preparing a report on a multicenter study he led of vitamin E and the diabetes drug metformin for NASH in children.

Posted: 4/30/2010 2:22:00 PM

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FDA adds boxed warning to propylthiouracil

From Endocrine Today:

The FDA has added a boxed warning to propylthiouracil to include information on reports of severe liver injury and acute liver failure, of which some have been fatal, in both adult and pediatric patients.

Propylthiouracil is used to reduce thyroid hormone levels and to decrease symptoms associated with hyperthyroidism, but is not recommended for use in pediatric patients except in rare instances where other treatments are not appropriate.

The new warning states that, “for those being started on treatment for hyperthyroidism, it may be appropriate to reserve use of propylthiouracil for those who cannot tolerate other treatments such as methimazole, radioactive iodine or surgery.” However, propylthiouracil may be the treatment of choice before and during the first trimester of pregnancy due to the occurrence of birth defects observed with methimazole (Tapazole, King Pharmaceuticals).

In addition, the FDA is requiring that a Medication Guide be issued to patients filling a prescription for propylthiouracil, as part of a Risk Evaluation and Mitigation Strategy.

Both the boxed warning recommendations and the medication guide requirement are based on the FDA’s postmarketing review of safety reports in addition to meetings with the American Thyroid Association, the National Institute of Child Health and Human Development, and the pediatric endocrine clinical community.

Posted: 4/26/2010 1:16:00 PM

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New bipolar treatment 'as effective as olanzapine'

From Healthcare Republic:

A new atypical antipsychotic is an effective long-term treatment for patients with bipolar mania, according to recently released data.

The findings of an extension study presented at the 18th European Congress of Psychiatry in Munich on 28 February suggest that asenapine has comparable efficacy and tolerability to olanzapine (Zyprexa).

Asenapine is currently awaiting European approval for the treatment of schizophrenia and manic episodes associated with bipolar disorder. It has antagonist activity at a range of serotonin, alpha-adrenergic, dopamine and histamine receptors.

Schering-Plough (now Merck) applied in May 2009 for European approval to market asenapine, under the trade name Sycrest. The drug is already available in the US as Saphris.

Posted: 4/20/2010 11:43:00 AM

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Popular anticonvulsant drugs raise suicide risks

From Reuters:

Widely used anticonvulsant drugs, including Pfizer's Neurontin and Novartis' Trileptal, may increase the risk of suicide, attempted suicide and violent death in patients taking them for the first time, U.S. researchers said on Tuesday.

Compared with Johnson & Johnson's generic epilepsy drug topiramate or Topamax, the team found an increased risk for suicide in new users of Neurontin, sold generically as gabapentin, GlaxoSmithKline's Lamictal or lamotrigine, Novartis' Trileptal or oxcarbazepine and Cephalon's Gabitril or tiagabine.

In one analysis, the team also found an increased risk of suicide with the drug valproate sold by Sanofi-Aventis as Epilim and as Depakine in the United States by Abbott Laboratories Inc.

In 2008, the U.S. Food and Drug Administration required that all drugs in the anticonvulsant class carry a warning that they double the risk of suicidal thoughts and behaviors, based on a so-called meta-analysis of nearly 200 clinical trials.

But the analysis was not large enough to show which drugs in the class were risky. And they are prescribed for a range of conditions.

Anticonvulsant drugs are chiefly used for patients with epilepsy, but the drugs have been aggressively promoted, in some cases for conditions they are not approved to treat, such as bipolar disorder, pain and migraine headaches.

While doctors are free to prescribe medicines as they see fit, drugmakers are only allowed to promote them for uses approved by the FDA.

West Coast troops feel the effects of Spice ban

From The Marines:

Since the Marine Corps Forces Pacific officially banned two of the nation's popular designer drugs last December, numerous Marines and sailors have been paying the price for violating the new restriction.

According to MARFORPAC Order 5355.2, Marines are prohibited from the actual or attempted possession, use, sale, distribution or manufacture of Spice, Salvia, or any derivative, analogue or variant of either substance.

Spice is a mixture of medicinal herbs laced with synthetic cannabinoids or cannabinoid mimicking compounds known to cause decreased motor function, loss of concentration and impairment of short-term memory. It is found in Mexico; can be chewed or smoked, and has also been known to be used sometimes for religious purposes.

Salvia divinorum is an herb that is known to cause hallucinations, changes in perception, body or object distortion, loss of coordination, dizziness and other psychological and physical effects, said Matthew W. Johnson, Ph.D., instructor, Department of Psychiatry, Johns Hopkins University School of Medicine, during a testimony on regulation of the substance.

The use of Spice and Salvia directly compromises the safety, welfare, security and good order and discipline within the command, states the order.

Marines and sailors who violate the order are subject to administrative or disciplinary action under the Uniformed Code of Military Justice. Civilians, contractors and family members are subject to a range of administrative action, including potential debarment from base and/or loss of employment.

Posted: 4/15/2010 9:01:00 AM

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Hallucinogens Have Doctors Tuning In Again

From The New York Times:

As a retired clinical psychologist, Clark Martin was well acquainted with traditional treatments for depression, but his own case seemed untreatable as he struggled through chemotherapy and other grueling regimens for kidney cancer. Counseling seemed futile to him. So did the antidepressant pills he tried.

Nothing had any lasting effect until, at the age of 65, he had his first psychedelic experience. He left his home in Vancouver, Wash., to take part in an experiment at Johns Hopkins medical school involving psilocybin, the psychoactive ingredient found in certain mushrooms.

Scientists are taking a new look at hallucinogens, which became taboo among regulators after enthusiasts like Timothy Leary promoted them in the 1960s with the slogan “Turn on, tune in, drop out.” Now, using rigorous protocols and safeguards, scientists have won permission to study once again the drugs’ potential for treating mental problems and illuminating the nature of consciousness.

After taking the hallucinogen, Dr. Martin put on an eye mask and headphones, and lay on a couch listening to classical music as he contemplated the universe.

Today, more than a year later, Dr. Martin credits that six-hour experience with helping him overcome his depression and profoundly transforming his relationships with his daughter and friends. He ranks it among the most meaningful events of his life, which makes him a fairly typical member of a growing club of experimental subjects.

Researchers from around the world are gathering this week in San Jose, Calif., for the largest conference on psychedelic science held in the United States in four decades. They plan to discuss studies of psilocybin and other psychedelics for treating depression in cancer patients, obsessive-compulsive disorder, end-of-life anxiety, post-traumatic stress disorder and addiction to drugs or alcohol.

The results so far are encouraging but also preliminary, and researchers caution against reading too much into these small-scale studies. They do not want to repeat the mistakes of the 1960s, when some scientists-turned-evangelists exaggerated their understanding of the drugs’ risks and benefits.

Because reactions to hallucinogens can vary so much depending on the setting, experimenters and review boards have developed guidelines to set up a comfortable environment with expert monitors in the room to deal with adverse reactions. They have established standard protocols so that the drugs’ effects can be gauged more accurately, and they have also directly observed the drugs’ effects by scanning the brains of people under the influence of hallucinogens.

Although federal regulators have resumed granting approval for controlled experiments with psychedelics, there has been little public money granted for the research, which is being conducted at Hopkins, the University of Arizona; Harvard; New York University; the University of California, Los Angeles; and other places.

The work has been supported by nonprofit groups like the Heffter Research Institute and MAPS, the Multidisciplinary Association for Psychedelic Studies.

Researchers are reporting preliminary success in using psilocybin to ease the anxiety of patients with terminal illnesses. Dr. Charles S. Grob, a psychiatrist who is involved in an experiment at U.C.L.A., describes it as “existential medicine” that helps dying people overcome fear, panic and depression.

Posted: 4/12/2010 9:37:00 AM

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Highly touted heart drug Multaq not as good as generics, cardiologists say

From the Los Angeles Times:

Dronedarone, a highly touted drug targeted at atrial fibrillation and sold under the brand name Multaq, is only half as effective as the generic drug amiodarone and does not appear to have fewer side effects, researchers from the Cedars-Sinai Medical Center reported Monday. It should be used only as a second- or third-line drug if all others fail, the team reported. The report, which is based on an examination of existing clinical trials rather than new research, represents further bad news for what was once thought to be a potential blockbuster drug with billions of dollars of annual sales.

Amiodarone, which is sold generically and under the brand name Cordarone, is an effective medication for controlling fibrillation. But it has severe potential side effects, including damage to the thyroid and lungs. Dronedarone was developed by Sanofi-Aventis as an alternative to amiodarone. It has a similar structure, but animal tests suggested it had fewer complications. The first clinical trial of the drug, in patients at moderate- to high-risk for hospitalizations and death from atrial fibrillation, showed that it doubled the rate of death, and the study was terminated prematurely. The FDA rejected the marketing application and suggested the company find applications where the benefit would exceed the risk.

A second major trial in patients with low to moderate risk found that the drug reduced hospitalizations resulting from atrial fibrillation, but not deaths. The FDA approved the drug, but allowed it to be marketed only for reducing hospitalizations.

European regulatory authorities demanded a head-to-head study of amiodarone and dronedarone. That study, which has yet to be published, found that dronedarone was only half as effective as amiodarone in preventing hospitalizations and deaths, but that it was slightly better tolerated -- although the difference was not statistically significant.

"The overall assessment is that dronedarone has only modest efficacy and no clear-cut safety advantage," Kaul said in an interview. Amiodarone, in contrast, has "a huge cost advantage." Multaq costs about $9 per day, and generic amiodarone costs pennies. "It's cheap, so why would you want to use an expensive, ineffective alternative?"

Kaul also thinks the side effects of amiodarone are a red herring. They appeared when a 400-milligram dose of the drug was routinely used, "but over the last 10 years, we have been using a 200-milligram dose and don't see the problems. I personally haven't seen any example of lung toxicity in the last 10 years.

Posted: 4/8/2010 9:34:00 AM

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Sharp Rise in U.S. Military Psychiatric Drug Use and Suicides

From The Huffington Post:

One in six service members is now taking at least one psychiatric drug, according to the Navy Times, with many soldiers taking "drug cocktail" combinations. Soldiers and military health care providers told the Military Times that psychiatric drugs are "being prescribed, consumed, shared and traded in combat zones."

The Navy Times also noted that there has been a large increase in military suicides. From 2001 to 2009, the Army's official suicide rate increased from 9 per 100,000 soldiers to 23 per 100,000. During that same period, the Marine Corps suicide rate increased from 16.7 per 100,000 soldiers to 24 per 100,000.

A Military Times investigation of records obtained from the Defense Logistics Agency (DLA) revealed that the DLA spent $1.1 billion on psychiatric and pain medications from 2001 to 2009, and that there was a 76 percent increase in psychiatric drugs. DLA records show:

Antipsychotic drugs spiked most dramatically -- orders jumping by more than 200 percent.
• Orders for anti-anxiety drugs and sleeping pills such as Valium and Ambien increased 170 percent.
• Orders for antiepileptic drugs (also known as anticonvulsants) such as Depakote, routinely used as psychiatric medications, increased 70 percent.
• 40 percent increase in antidepressants.

Investigators found that antipsychotic and antiepileptic drugs, approved for bipolar disorder and schizophrenia, are now commonly used to treat post-traumatic stress disorder (PTSD) symptoms such as nightmares, nervousness and anger outbursts. The use of antipsychotic drugs for non-psychotic conditions such as PTSD is called "off-label" prescribing.

In February 2010, Brig. Gen. Loree Sutton, the Army's highest-ranking psychiatrist, reported to Congress that 17 percent of the active-duty force and as much as 6 percent of deployed troops are on antidepressants.

Many of these psychiatric drugs prescribed to service members can also impair motor skills, reduce reaction times, and generally make one more sluggish -- or what soldiers call "stupid." So in addition to antidepressants potentially resulting in increased suicidality, other psychiatric drugs can make deployed soldiers feel less capable of protecting themselves and their buddies.  

Bisphenol-A (BPA) Found Throughout Oceans

From Wired:

A survey of 200 sites in 20 countries around the world has found that bisphenol A, a synthetic compound that mimics estrogen and is linked to developmental disorders, is ubiquitous in Earth’s oceans.

Bisphenol A, or BPA, is found mostly in shatter-proof plastics and epoxy resins. Most people have trace amounts in their bodies, likely absorbed from food containers. Its hormone-mimicking properties make it a potent endocrine system disruptor.

In recent years, scientists have moved from studying BPA’s damaging effects in laboratory animals to linking it to heart disease, sterility and altered childhood development in humans. Many questions still remain about dosage effects and the full nature of those links, but in January the U.S. Food and Drug Administration announced that “recent studies provide reason for some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children.”

At an American Chemical Society  meeting last year, they described how soft plastic in seawater doesn’t just float or sink intact, but can break down rapidly, releasing toxins. In their new findings, they showed that BPA-containing hard plastics can break down too, and found BPA in ocean water and sand at concentrations ranging from .01 to .50 parts per million.

As for what those numbers mean for public and environmental health, it’s hard to say. BPA can cause reproductive disorders in shellfish and crustaceans, and doses below a single part per trillion can have cell-level effects, but the path from water and sand to ocean animals needs to be studied.

One disturbing possibility is that BPA could bioaccumulate, with animals eating BPA-tainted animals that have eaten BPA-tainted animals, finally reaching high concentrations in top-level ocean predators and the humans who eat them. For that to happen, BPA would have to be stored in fatty tissue, rather than passing quickly through the body.

In a 2009 Environmental Health Perspectives study of BPA concentrations in people who had recently fasted, Shanna Swan, a University of Rochester environmental medicine specialist,  found that BPA levels remained high longer than expected. It’s possible that BPA indeed accumulated in their fat, said Swan.

The BPA contamination likely comes from a mix of boat paint and plastic. About three million tons of BPA-containing plastics are produced each year. The United Nations estimates that the average square mile of ocean contains 46,000 pieces of plastic trash.

Posted: 4/2/2010 8:41:00 AM

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