Eisai Co and Pfizer Inc said they won U.S. regulatory approval for a higher dose once-daily version of Aricept, a drug that treats Alzheimer disease.

Eisai, Japan’s No. 4 drugmaker, said in March it expected annual U.S. sales of the drug, its flagship product, to fall 60 percent to $800 million from $2 billion between 2011 and 2013 with the expiration of its patent for the drug looming.

The U.S. Federal Drug Administration approved a 23 mg tablet version of the drug, which treats moderate-to-severe Alzheimer’s. About 3.5 million Americans over the age of 65 suffer from the disease.

(Reporting by Phil Wahba; editing by Carol Bishopric)

Technorati Tags: Alzheimer disease, Aricept, Eisai Co, Pfizer Inc

Clinical trials aimed at pinpointing emerging safety problems with drugs already on the market should only be conducted when other, less invasive research is not possible, a U.S. advisory group said on Friday.

The Institute of Medicine’s report, requested by U.S. Food and Drug Administration officials, comes ahead of a highly-anticipated meeting next week on GlaxoSmithKline Plc’s diabetes drug Avandia, that has come under fire for potential heart risks.

Glaxo is conducting a randomized, controlled trial called TIDE to compare Avandia to Takeda Pharmaceutical Co’s rival drug, Actos, after safety concerns emerged with Avandia that the FDA and its advisers concluded were unclear.

While the IOM did not target the Avandia trial in particular, FDA Commissioner Margaret Hamburg asked the independent, nonprofit medical group to weigh in with at least an initial finding on general ethical issues involving the safety of studying the risks of drugs already in use.

The FDA called in 2007 for the TIDE study, which aims to enroll 16,000 patients and end in 2015, although some critics say it could take longer.

Analyses of other data since then have convinced some researchers that Avandia’s risks are greater than those of Actos and have repeatedly called for the trial to be halted.

Glaxo has defended its drug, saying data overall shows it does not increase the risk of heart attack, stroke or death.

On Tuesday and Wednesday, FDA’s panel of outside experts will weigh numerous studies and analyses before recommending whether Avandia should remain on the market, be pulled from the market, or various options in between.

They also will be asked to weigh in on the TIDE trial.

In its report, the IOM said randomized controlled trials should only be done when “a responsible policy decision cannot be made based either on the existing evidence or on evidence from new observational studies.”

It also said studies of real world use of a drug — known as observational studies and often done by reviewing insurance claims and other databases — can yield strong data.

In separate FDA documents released on Friday, FDA staff scientists were split over whether the TIDE trial should continue just as they are divided over whether another major Glaxo trial, RECORD, showed excessive heart-attack risks with Avandia.

Some staff also pointed to studies done since 2007, including an FDA analysis of 52 trials on the prescription drug, as well as a review of Medicare data that showed a greater risk of heart attack and other complications with Glaxo’s drug.

“Based on these findings, any proposed head-to-head trial of rosiglitazone vs. pioglitazone is unethical and exploitative,” agency reviewers David Graham and Kate Gelperin wrote.

Rosiglitazone is the generic name for Avandia, and pioglitazone is the generic name for Actos.

Another FDA scientist, clinical reviewer Karen Mahoney, said that the TIDE trial does not have many of the limitations of the earlier RECORD study and could be illuminating.

“This trial, if it continues to completion, has the potential to address the question of the cardiovascular safety of rosiglitazone more definitively,” she wrote in a separate memo.

(Reporting by Susan Heavey; Editing by Tim Dobbyn)

Technorati Tags: Actos, Avandia, drug safety trials, pioglitazone, Rosiglitazone

The U.S. House of Representatives has approved a ban on some patent agreements between brand name and generic drug companies, deals which a federal agency says slow the arrival of cheaper generic drugs to market.

The House, voting late on Thursday, approved the measure as part of its approval of money to pay for President Barack Obama’s Afghanistan troop increase.

The measure, backed by the Federal Trade Commission, must now be considered by the Senate. The U.S. House has approved the measure previously but it has died in the Senate.

The Generic Pharmaceutical Association (GPhA) said it was disappointed in the vote.

“As this legislation moves to the Senate, GPhA will expand its efforts to point out that a curb on settlements will not hasten generic market entry, but rather will delay the launch of new and affordable generic medicines,” the group said.

“The unintended consequence of these restrictions on settlements will significantly harm the millions of Americans who rely on generic drugs,” it said in a statement.

But the House move pleased FTC Chairman Jon Leibowitz, who has made stopping the deals a centerpiece of his tenure on the commission. The FTC says the deals break antitrust law in instances where brand name drug companies essentially pay generic companies to delay entering the market.

“Congress has taken a critical step toward ending a practice that is dramatically increasing the cost of prescription drugs,” said Leibowitz.

The FTC has estimated that the deals — which often come as part of settling patent litigation — cost consumers about $3.5 billion a year by delaying access to generics.

(Reporting by Diane Bartz; Editing by Tim Dobbyn)

Technorati Tags: brand name drug, cheaper generic drugs, drug patent, generic drug, generic medicines, prescription drugs

They’re out there on the Web: Sites that offer tips to successful purging or water-only fasts; others that list methods of hiding rapid weight loss from parents and doctors.

If the proliferation of these pro-anorexia and pro-bulimia Web sites isn’t bad enough, eating disorder experts say they now have to contend with “pro-ana” and “pro-mia” bloggers and “thinspiration” Twitter updates sent right to an interested party’s mobile phone.

“They are reaching very vulnerable youth,” said Dina Borzekowski, an associate professor in Johns Hopkins Bloomberg School of Public Health. “When you have the Internet used all times of the night, kids have easy access to it. It’s anonymous. They can gain support for what they’re doing and information.”

For their new study, Borzekowski and colleagues conducted a systematic review of 180 pro-eating disorder sites. What they found was both surprising and frightening.

About 91 percent of sites were open to the public — though many warned that “wannabes” should stay away — and about 79 percent had interactive features, such as calorie and body-mass index (BMI) calculators.

About 16 percent had a “creed” or “oath to Ana,” such as the “Thin Commandments,” or 10 rules for eating disorders, such as: “Thou shall not eat without feeling guilty,” “Thou shall not eat fattening food without punishing oneself afterward,” and “What the scale says is the most important thing.”

About 42 percent provided a venue for posting artwork and poetry, some of it disturbing:

“some look at us and call us crazy
how little they really know
they pass us by and stare
like we’re in some sickly show
don’t they see?
It is not us who is at fault
They kill their bodies with fats and grease
but we give our bodies nothing at all.”

“Thinspiration,” such as photos or videos of very thin models and actresses, were on 85 percent of the sites. And about 43 percent provided specific instructions on concealing eating disorders, according to the study.

Patients with eating disorders have been known to go to great lengths to hide their weight loss, explained Dr. Ira Sacker, an eating disorder specialist, including drinking lots of water before being weighed and hiding weights in their clothes.

About one-third of sites did include information about recovery or treatment, though only 13 percent of sites contained an overt statement that eating disorders are a problem.

“Some people who create these messages stand behind what they are doing, while another fraction realize this is troubling and they are suffering,” Borzekowski, said. “You get mixed messages.”

The study is published in the June 17 issue of the American Journal of Public Health.

Previous research suggests that teens exposed to pro-eating disorder Web sites do have higher levels of body dissatisfaction compared to adolescents that have not been exposed. Other studies found that teens who spent time on these sites tend to have harder-to-treat eating disorders, according to background information in the study.

Sacker has been treating patients with eating disorders for some 40 years. He can remember his dismay when he first started seeing pro-eating disorder sites pop up in the early 1990s.

“These are really scary,” Sacker said. “The people on these sites want to be using the eating disorder as their identity, and they want to communicate with others like them. That makes them believe there is a safety in it and a community behind it, which reinforces that what they are doing is OK. It’s almost like a cheerleading group.”

In 2001, the search engines Yahoo and MSN agreed to shut down overtly pro-eating disorder sites, according to background information in the article.

It didn’t make much of a dent, Sacker said. Over time, online offerings for those with eating disorders have only gotten more sophisticated. The text and a photos of skeletal models has morphed into videos, voice-overs, blogs and Facebook groups.

“Parents need to be aware and have boundaries about what their kids are doing on Facebook or on these sites,” Sacker said. “Even though some sites talk about recovery, the majority can worsen or prolong the illness.”

Though there are many exceptions, the typical profile of someone with an eating disorder is a highly intelligent, motivated perfectionist who “feels they are not good enough, no matter what they do, and are looking for some form of control,” Sacker said.

The content of pro-eating disorder sites reflected those themes, with 83 percent talking about “success,” 81 percent “control,” 80 percent “perfection” and 76 percent “solidarity,” according to the paper.

People with eating disorders may also have depression, anxiety and obsessive-compulsive disorder or other mental health conditions.

The obsession with weight loss obscures all else, Sacker said. “They become totally preoccupied by looking at mirrors. They know more about nutrition than most nutritionists. They lose friends and become socially isolated because of it,” Sacker said.

Medications, including mood stabilizers, anti-anxiety drugs and antidepressants can help some with eating disorders, Sacker said.

Technorati Tags: eating disorders, pro eating disorder, rapid weight loss, Weight Loss

Medicare patients in some regions of the United States spend significantly more on drugs than older folks elsewhere in the country, a new report finds.

But higher drug spending doesn’t mean they spend less on doctor visits or hospitalizations, the researchers say.

“Our findings reinforce the importance of understanding the drivers of geographic variation, since increases in medical spending or pharmaceutical spending do not appear to be associated with offsetting savings in the other realms,” said lead researcher Yuting Zhang, an assistant professor of health economics at the University of Pittsburgh Graduate School of Public Health.

“Spending on pharmaceuticals itself is variable and thus warrants scrutiny similar to that given to medical spending in order to glean lessons about optimal prescribing, insurance characteristics, and resource allocation,” she added.

The report is published online June 9 in the New England Journal of Medicine.

For the study, Zhang’s team looked at spending on drugs and other medical services among Medicare patients in 2007 at 306 hospital-referral regions across the country.

“Widespread geographic variations exist, with some regions spending almost twice as much as others,” Zhang said.

As part of their calculations, the researchers considered factors such as differences in costs, insurance and overall health in the different geographic areas.

Overall, drugs accounted for more than 20 percent of total medical costs, but the researchers found substantial regional variations in drug spending.

Manhattan, in New York City, had the highest Medicare spending on drugs at $2,973 per patient a year, while Hudson, Fla., had the lowest at $1,854, the investigators found.

Los Angeles, Montana, Alaska and Hawaii were other areas of high drug spending by Medicare beneficiaries, while regions of low spending include parts of Arizona, New Mexico, Oregon and Maine, according to the report.

Spending on non-drug health care also varied by region, with some regions spending twice as much as the lowest, the group found.

These differences in other health care services were only weakly associated with spending on drugs. “The areas where drug spending is the highest have neither systematically higher-than-average nor lower-than-average non-drug medical spending,” Zhang said.

Health conditions that require patients have both drugs and frequent doctor visits might be one explanation for the discrepancy, Zhang said.

Regional differences in spending might also be caused by various non-medical factors, she said.

“It is possible that more affluent people might be less sensitive to price, so they tend to use more brand-name drugs, even though generics are available,” Zhang said. “Physicians from different regions might have different prescribing habits, or some plans or states might have stricter regulations regarding step therapy or prior authorization, like using preferred and cheaper drugs first before using more expensive non-preferred drugs.”

Joseph P. Newhouse, professor of health policy and management at Harvard University and report co-author, attributes the variations in drug spending to prices and prescribing habits.

“In the higher-spending drug regions, doctors are prescribing more drugs and more expensive drugs,” Newhouse said.

But the impact on health isn’t clear, he said. “We don’t know if the low regions are under-prescribing and the high regions are over-prescribing or both, so we can’t say,” Newhouse said.

The next step is to determine what differences exist in terms of patient outcomes, he added.

Joe Baker, president of the Medicare Rights Center, a consumer service organization, said the study highlights the need to develop “health care standards that are nationwide.”

A lot of medicine is “local, like politics,” Baker said. “Doctors get into certain practice patterns in a certain locality, and that is driven by medical societies and other community organizations doctors work in and not necessarily broader-based quality or practice standards,” he said.

“We need to find out whether doctors are using ‘best practices’ to prescribe drugs, or are they just doing it willy-nilly,” he said.

Technorati Tags: Drug Spending, health care services, medical spending, prescribing habits

Italy is taking new steps to rein in healthcare spending and reduce the country’s drugs bill by imposing a cut in generic drug prices and curbs on reimbursement for more expensive medicines.

Italy joins a growing list of European countries that have acted to cut drug prices as part of austerity measures to tackle runaway budget deficits.

Under a package of measures, set out in a 176-page austerity program published on Tuesday, the price of off-patent generic drugs will be cut by 12.5 percent from June 2010 until the end of this year.

From 2011, reimbursement of generics will be limited to the cheapest version of a medicine within four therapeutic categories, with the lowest price established by a tender system.

The introduction of a tender system for purchases of generics follows similar action by Germany, where tendering has led to reduced prices.

Purchases of goods and services by the state health service above reference prices will have to be justified.

The measures should save the state 600 million euros ($733.8 million), according the austerity package.

($1=.8176 Euro)

(Reporting by Silvia Aloisi and Ben Hirschler; Editing by Hans Peters)

Technorati Tags: cut drug costs, generic drug prices, generic drugs, Italy

U.S. regulators are investigating potential risks from Abbott Laboratories Inc’s HIV drug Kaletra, GlaxoSmithKline Plc’s prostate drug Avodart and other medicines.

The Food and Drug Administration said on Monday it was probing reports of liver toxicity with patients who used Kaletra to prevent HIV infection after exposure to the AIDS virus.

The agency also said it was investigating cases of male breast cancer in patients treated with Avodart as well as Merck & Co’s prostate drug Proscar and baldness treatment Propecia.

The FDA releases a quarterly list of safety probes to inform the public about early investigations of potential side effects that have been reported. The list released on Monday covered issues identified between October and December 2009.

Being on the list does not mean the FDA has concluded the drug causes the specific risk, the agency said.

Abbott spokeswoman Elizabeth Hoff said the company added information to Kaletra’s label last week noting that patients who took the drug to prevent HIV infection were among those who should undergo liver monitoring tests.

The label says some reported cases of liver dysfunction were serious. “However, a definitive causal relationship with Kaletra therapy has not been established,” the drug label says.

Merck spokeswoman Pam Eisele said the prescribing instructions for Proscar and Propecia already mention cases of male breast cancer seen in clinical trials. Both drugs contain the same active ingredient.

“A causal relationship has not been established,” she said.

Glaxo spokeswoman Sarah Alspach said the company evaluates all reported cases of breast cancer in men taking Avodart.

“Based on reports evaluated to date, there is not conclusive evidence of a causal association between Avodart and male breast cancer,” she said.

Technorati Tags: AIDS virus, Avodart, breast cancer, Kaletra, prevent HIV infection, propecia, Proscar

The European Union insisted Monday that a free-trade deal being negotiated between the trading bloc and India will not hurt the South Asian nation’s exports of “life-saving” generic drugs.

The assurance came after humanitarian medical group Medecins Sans Frontieres (MSF) said the free trade deal could mean people in developing nations no longer being able to have access to cheap generic drugs from India.

The EU’s ambassador to India said Brussels had no interest in halting the manufacture and export of generic drugs from India, known as the “pharmacy of the developing world”.

The agreement is not intended to limit India’s capacity “to produce and export life-saving (generic) medicines”, Daniele Smadja, head of the Delegation of the European Union in New Delhi, told reporters in the Indian capital.

Smadja said a leaked version draft provisions of part of a proposed free trade agreement between India and the EU covering generic drugs that had been highlighted by MSF was “not the text which will be in the agreement.”

The text will be “subject to discussions and negotiations”, she said.

India is the source of 80 percent of the AIDS medicines used in projects run by MSF, which says it fears the trade pact could deal a fatal blow to India’s status as the leading manufacturer and exporter of non-branded medicines.

The 27-member EU and India are aiming to conclude negotiations on a free trade agreement by late October when a summit meeting is planned, Smadja said.

India?s exports to the European Union, its largest trading partner, in 2008-09 are estimated at 39.35 billion dollars, while imports totalled 42.73 billion dollars.

“I am confident that with political will we will manage to find a mutually beneficial agreement,” the EU ambassador to India said.

The EU, which sees a free-trade deal with New Delhi as helping boost its presence in fast-growing Asia, and India, the world’s second most populous nation, launched talks on a free trade agreement in 2007.

Technorati Tags: cheap generic drugs, European Union, generic drugs, generic drugs from India

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