The US Army’s surgeon general on Monday expressed concern about “over-medication” of soldiers returning from combat, saying the military is closely tracking how drugs are prescribed to troops.

The top medical officer in the army, Lieutenant General Eric Schoomaker, said the increasing use of prescription drugs for soldiers recovering from combat duty in Iraq or Afghanistan reflected a wider trend in the country to treat pain primarily through medication.

But he told reporters: “I can tell you that we are concerned about over-medication.”

The general said that “we’re very concerned about the panoply of drugs that are being used and the numbers of drugs that are being used.”

“We are monitoring it very, very closely,” he said.

Prescription orders for psychiatric and pain medicines for troops have increased dramatically since 2001, according to a Military Times report in March, with one in six service members on some form of psychiatric drug.

About 15 percent of soldiers said they had abused prescription drugs in the past month, according to a Pentagon survey carried out in 2008 and released in December.

Lawmakers have urged the military to examine a possible link between a rise in suicides among troops and the use and abuse of prescription drugs.

Schoomaker said he had led a review looking at prescription drugs and his task force had promoted alternatives to pain killers, including “yoga, meditation, acupuncture, movement therapy, lots of other ways of approaching pain management.”

The army surgeon general made his comments at a news conference in which the he and other officers took issue with a New York Times account of a center in Colorado set up to help soldiers recover from mental or physical wounds in combat.

The Times, citing interviews with soldiers and health care workers, described the “warrior transition unit” at Fort Carson and similar posts as “warehouses of despair, where damaged men and women are kept out of sight, fed a diet of prescription pills and treated harshly by noncommissioned officers.”

But Schoomaker said about 81 percent of all soldiers at the transition centers expressed satisfaction with their treatment and about 90 percent of the troops at the Fort Carson center said they were satisfied with the care they received.

“And even with 90 percent satisfaction you’re going to have some people with very complex problems that are not going to be in that satisfied group,” he said, referring to the Times report.

About 26 percent of the soldiers at the transition center in Fort Carson were on a prescribed narcotic, with a clinical pharmacist closely monitoring the prescriptions, Colonel Jimmie Keenan of the military hospital at Fort Carson, told reporters by telephone.

Technorati Tags: pain killers, pain management, prescription drugs, prescriptions monitoring

Some anticonvulsants used to treat epilepsy and other conditions may increase the risk of suicide, attempted suicide or violent death, a new study finds.

While these drugs are used primarily to control epileptic seizures, they are also approved treatments for other conditions, such as bipolar disorder, mania, migraine and chronic nerve pain.

“Anticonvulsant medications have important therapeutic benefits, but they also have associated risks that both provider and patient need to remain aware of,” said study author Dr. Elisabetta Patorno, a research fellow at Brigham and Women’s Hospital and Harvard Medical School in Boston.

“Physicians should discuss associated risks and benefits with their patients, and together determine the best treatment course for the underlying medical condition,” she said. “Both patients and health-care professionals should be alert to early symptoms that might potentially be associated with suicidal risk.”

The report is published in the April 14 issue of the Journal of the American Medical Association.

For the study, Patorno’s group used the HealthCore Integrated Research Database, which has data on prescriptions and adverse side effects. Specifically, they looked at almost 300,000 patients aged 15 and older in 14 states who started taking anticonvulsant medications between July 2001 and December 2006.

During that period, the researchers identified 801 attempted suicides, 26 completed suicides and 41 violent deaths — 868 combined suicidal acts or violent deaths.

Patorno’s group found an increased risk of suicidal acts among patients taking the anticonvulsants gabapentin (Neurontin), lamotrigine (Lamictal), oxcarbazepine (Trileptal), tiagabine (Gabitril) and valproate, compared with people taking the anticonvulsant topiramate (Topamax).

In 2008, the U.S. Food and Drug Administration instructed manufacturers of anticonvulsants to include a label warning about the increased risk of suicidal thoughts or actions associated with these drugs.

“I do not think that the results should affect physician behavior at this time,” said Dr. Orrin Devinsky, director of the Epilepsy Center at NYU Langone Medical Center.

“Anti-epileptic drugs are used primarily in patients with epilepsy and patients with psychiatric disorders; both groups have well-known increased risk for suicidal behavior,” Devinsky said.

This study found the probability of suicidal acts after starting topiramate were relatively low compared to four other anticonvulsant medications, he said.

“The question is if there was a bias with regards to patients selected on these medications, and also whether these results, which were statistically significant, would be replicated and have clinical significance,” Devinsky said.

“It is possible that a new cohort would reveal a different profile, reflecting the random nature of the patient population and a selection bias of how doctors prescribe drugs,” he added.

Dr. Ewald Horwath, a professor of psychiatry & behavioral sciences at the University of Miami Miller School of Medicine, said the study may be misleading.

“The study did not take adequate account of why people were taking the anticonvulsant,” Horwath said. The authors noted that many of the people in the study were taking these drugs to treat bipolar disorder and depression, “conditions that are associated with higher suicide rates,” he said.

Horwath noted that another study of patients with bipolar disorder found these drugs actually decreased the risk for suicide.

Technorati Tags: Anti-epileptic drugs, anticonvulsant medications, anticonvulsants, bipolar disorder, chronic nerve pain, Lamictal, Neurontin, psychiatric disorders, suicidal risk, treat epilepsy, trileptal

The first human trials of the latest design of an artificial pancreas for people with type 1 diabetes found the device worked without causing low blood sugar (hypoglycemia).

Ideally, this type of automated device would finally free people with type 1 diabetes from the insulin injections that many require each day, while relieving them of the constant need to check blood sugar levels and monitor the food they eat accordingly.

The device, produced through a collaboration of experts from Boston University, Massachusetts General Hospital and Harvard Medical School, delivers two hormones that are deficient in type 1 diabetes — insulin, which keeps blood sugar levels from going too high after a meal, and glucagon, a naturally occurring hormone that prevents blood sugar levels from dropping too low.

Because the device doesn’t rely on human input, it’s called a “closed-loop” system.

“A bi-hormonal closed-loop system is feasible and it can give you good average blood sugar readings,” explained one of the device’s designers, Edward Damiano, an associate professor of biomedical engineering at Boston University, and the father of a son with type 1 diabetes.

“What we’ve developed is automated decision-making software that uses a mathematical formulation to infuse varying amounts of insulin and glucagon when needed,” he explained.

Type 1 diabetes is a disease in which the body’s immune system — which normally protects you from infections and other diseases — turns against healthy cells. In type 1 diabetes, the immune system attacks beta cells in the pancreas, effectively destroying the body’s ability to produce insulin and control blood sugar levels.

What many people don’t realize, however is that beta cells aren’t the only ones damaged by the autoimmune attack. Alpha cells, which produce the hormone glucagon, are also damaged. Damiano’s colleague, Dr. Steven Russell from Harvard, said, “There is a functional deficiency in alpha cells in type 1 diabetes and they don’t work properly. They don’t secrete glucagon as they should, so an extra level of security is lost and you can wind up with hypoglycemia that can be scary and even life-threatening.”

That’s why they decided to add glucagon to their artificial pancreas to give it an added level of protection, said Russell.

In the current version of the device, the researchers tracked blood glucose via a special sensor placed into a vein. Future versions of the device will use currently available continuous blood glucose monitors (CGMs), but for this trial the researchers wanted an extremely accurate way to measure blood sugar levels so that the only variable was the mathematical formulation used to program the delivery of insulin and glucagon.

Eleven people with type 1 diabetes were included in the initial tests, and were studied in 27-hour experiments. During that time, they were hooked up to the artificial pancreas and given carbohydrate-rich meals (carbohydrates are transformed into glucose in the body).

The device responded to the rise in blood sugar levels by administering insulin. In six people, the device achieved an average blood glucose level of 140 milligrams per deciliter (mg/dl), which is well within the American Diabetes Association guidelines for care. However, five people absorbed the insulin much slower than expected, and ended up with low blood sugar levels serious enough to require intervention with additional food.

The researchers were surprised by the significant difference in blood sugar absorption rates, but went back and adjusted the mathematical formulation, and retested the device in a second experiment. This time, they achieved an average blood glucose level of 164 mg/dl, which is slightly higher than the ADA’s goal. However, there were no instances of hypoglycemia that needed intervention.

The researchers said that people using the pump would rid themselves of the need for daily injections. Instead, they might just need to change the pump site every three days, and the glucose-monitoring site once per week. No one-site integration of hormone delivery and glucose monitoring has been developed yet, although that’s the ultimate goal.

In the next trial, the researchers hope to deliver at least some of the insulin prior to a meal, which is the standard treatment. Damiano said this may be accomplished with a pre-meal button, and the user could just choose whether they were having a small-, medium- or large-carbohydrate meal.

The next set of trials will also test a device that includes insulin only, because it would likely be available faster. The reason is that glucagon is currently only FDA-approved in a freeze-dried form as an injectable rescue medication. It’s not FDA-approved yet for delivering through an insulin pump in tiny doses, as it would be in an artificial pancreas. Both Damiano and Russell think it could be possible to have an insulin-only closed-loop system available for use by patients within five years or so.

“The goal of an artificial pancreas is to try to restore normal physiology as closely as possible, and this study demonstrates that this technology is real, and it’s good in real people,” said Aaron Kowalski, assistant vice president for glucose control research and research director of the Artificial Pancreas Project for the Juvenile Diabetes Research Foundation (JDRF). “We’ve talked for many years about the theoretical potential of a closed-loop system, and now we see the real potential. These technologies are going to be built into real systems and will have the potential to transform the management of diabetes.”

Results of the study were published in the April 14 issue of Science Translational Medicine.

Technorati Tags: Artificial Pancreas, blood sugar levels, insulin injections, Type 1 Diabetes

TUESDAY, April 6 (HealthDay News) — Hospitalizations caused by accidental and intentional abuse of prescription sedatives, tranquilizers and other painkilling drugs has risen dramatically over the last decade, new research reveals.

Hospital stays from an unintentional overdose of opioids (such as Vicodin and Percocet) and sedatives (such as Valium and Ativan) jumped 37 percent between 1999 and 2006, the study found. Intentional overdoses of these drugs skyrocketed by 130 percent in that time.

“We’re seeing a tremendous increase in serious overdoses associated with the use of prescription drugs,” said the study’s lead author, Dr. Jeffrey H. Coben, director of the Injury Control Research Center at the West Virginia University School of Medicine and a professor of emergency and community medicine.

“And while I know that people have seen headlines on Michael Jackson and Heath Ledger and Anna Nicole Smith, this is not a problem just contained to celebrities,” Coben stressed. “This is a problem that is dramatically on the rise throughout the country, and it’s very important that people understand that prescription drugs are very powerful, potentially life-threatening and need to be used as prescribed and with caution.”

In the United States, in fact, poisoning — which includes overdoses — now ranks as the second-leading cause of death from unintentional injury, according to the study.

The study, reported in the May issue of the American Journal of Preventive Medicine, presents a snapshot of prescription drug abuse drawn from a database that tracks hospitalizations nationwide.

The researchers found that hospitalizations that resulted from prescription opioid, sedative and tranquilizer use had increased 65 percent during the seven-year study period when accidental and intentional use were included.

The study authors also found that hospitalizations resulting from unintentional overdoses of these drugs increased 37 percent, compared with a 21 percent increase in hospitalizations attributed to unintentional poisoning from other drugs and substances, including so-called street drugs such as heroin, over-the-counter medications such as Tylenol and other prescription drugs.

Hospitalizations from all other causes increased just 11 percent, the study found.

There was a 130 percent rise in suicide-related overdoses of these drugs compared with a 53 percent increase in intentional overdoses of all other substances, according to the researchers.

The hospital data, however, did not show an increase in poisonings from all prescription drugs. Methadone use accounted for the largest relative leap in hospitalizations, rising 400 percent, but hospitalizations that resulted from barbiturate and antidepressant use dropped by 41 percent and 13 percent, respectively — trends that Coben said could be the result of changes in prescribing patterns.

In light of the findings, Coben highlighted steps that could be taken to try to reduce the chances of prescription drug overdoses.

“There’s pretty good consensus around certain measures. We do need to work with physicians and pharmacists to make sure there are better procedures in place to monitor who’s getting what and how frequently,” he said.

“There’s also a need to educate people better about the dangers associated with these meds and about how to use them and not to use them, and what to do when you’re finished using them,” Coben added. “And finally, there’s a role for the legal system in going after rogue pharmacies and Internet distribution of these medications. So I’m advocating a multi-factorial approach.”

Michael Von Korff, a senior investigator with Group Health Research Institute, part of the Seattle-based health-care system, described the study’s findings as consistent with other recent research.

“Our own work suggests that 3 to 4 percent of American adults — not just people with chronic pain — are now using opioids,” Von Korff said. “This is the treatment that 8 to 10 million Americans are using now, which means that many more people have these drugs in their medicine cabinets now and are using them. And when you increase exposure, there’s going to be increases in adverse events,” he added.

“As a result, the number of emergency room visits is increasing rapidly, and the number of fatal overdoses is increasing rapidly and the number of high school students using opioids for non-medicinal purposes is increasing rapidly,” Von Korff said. “So I’d say that this finding is sobering, but not surprising.”

Technorati Tags: ativan, painkilling drugs, Prescription Drug Abuse, prescription drugs, valium

NEW DELHI (Reuters) – India is ready to launch a formal dispute against the European Union at the World Trade Organization over EU seizures of Indian generic drugs, the Indian Trade Secretary said on Wednesday.

“I am ready. I have my legal briefs ready,” Rahul Khullar told Reuters, without saying when India could present a case.

New Delhi says it wants to solve the dispute “amicably” but there has been no breakthrough so far between India and its largest trading partner. Khullar said India was still holding out for a solution.

Khullar, a top civil servant key to Indian negotiations, also said the Doha world trade talks were “standing still” and India was waiting for the United States to move the talks forward.

A formal trade dispute has loomed for a long time between India and Brazil on one side and the EU on the other.

Developing countries believe the case, originally involving the seizure by Dutch customs of a blood pressure drug en route from India to Brazil, is a symbol of their mistreatment by rich nations and corporations.

India has said the drug shipments were consistent with WTO regulations. The issue is sensitive in a country with a thriving generic drugs industry and hundreds of millions of poor needing access to cheap medicine.

A spokesman for the EU said in response that the EU was taking the drugs seizures “very seriously” and had implemented measures that prevented further incidents.

“We are now revising the relevant EU legislation to ensure that trade in generics is not hindered when transiting through EU territory,” European Commission trade spokesman John Clancy said.

“However, we also need to acknowledge that there are serious problems of counterfeit medicines which are arriving and transiting in Europe,” he added.

STANDING STILL

Global demand for generic drugs from Indian drugmakers such as Dr Reddy’s Laboratories and Ranbaxy Laboratories and Cipla Ltd is booming as nations battle rising healthcare costs.

The Indian generics business boom has lured Western drug makers that want to raise exposure in fast-growing emerging markets.

The dispute over seizures has rumbled in the backdrop of negotiations between India and the 27-nation EU bloc for a free trade deal which both sides aim to seal by October.

Trade between India and the EU currently stands at 78 billion euros ($105 billion). Brussels says the pact could open up export opportunities worth $9 billion for India.

Negotiations began in 2007 but need to close differences on issues such as market access and the EU’s moves to link commerce to India’s performance on child labor and the environment.

Khullar reiterated New Delhi’s position to keep “extraneous” issues off the table, but did not elaborate.

Medical advocacy group Medecins Sans Frontieres has called India “the pharmacy of the developing world” and flagged concerns that the trade deal could tighten intellectual property rights on generic drugs and limit the poor’s access to cheap drugs.

New Delhi has said such concerns are unfounded.

Nations took stock of the Doha world trade talks in March, which look almost certain to miss their stated target of concluding by 2010.

One sticking point is that the United States, crucial to any deal, wants to see big emerging countries such as India and China open their markets more to foreign businesses.

But Washington has also drawn criticism for its perceived foot-dragging on the talks, which were launched late in 2001 to free up global trade flows and help poor countries develop.

It took six months for the U.S. to appoint two top trade negotiators, including its WTO ambassador.

“A stocktaking has told you exactly where we are, which is, we are exactly standing still. We haven’t moved,” Khullar said.

He went on to echo recent comments made by the European Union’s trade chief that it was up to the U.S. to push the talks forward.

“Now in the next stage, the Americans have been told, come to the table. What is it you (Washington) want? If you don’t come to the table with something that you want, then it’s your fault.”

Technorati Tags: blood pressure drugs, cheap drugs, cheap medicine, generic drugs industry, Indian generic drugs