A new study led by a federal drug safety expert ties the controversial diabetes drug Avandia to a higher risk of heart problems, strokes and deaths in older adults, and says it is more dangerous than a rival drug Actos.

The study, a huge review of Medicare records, comes two weeks ahead of a Food and Drug Administration hearing on Avandia’s safety. The lead author, Dr. David Graham, is an FDA scientist who wants the pill banned.

As many as 100,000 heart attacks, strokes, deaths and cases of heart failure may be due to Avandia since it came on the market in 1999, Graham said in an interview with The Associated Press.

Harms from Avandia are great enough to “put you in a hospital or in a cemetery,” he said.

Editors at the Journal of the American Medical Association rushed to release the study online on Monday, so the information would be available before the July 13-14 hearing, a spokeswoman said.

Avandia is a once-blockbuster drug for Type 2 diabetes, the most common form of the disease and the kind often tied to obesity. Avandia and Actos are pills that help the body make better use of insulin, a key digestive hormone.

The American Heart Association issued a statement reminding patients not to stop taking any medicine without talking with their doctors first. The new study is not definitive enough to prove harm but “deserves serious consideration” and should be discussed between patients and their doctors, the statement says.

Avandia has been under a cloud since May 2007, when a review of dozens of studies suggested it may raise the risk of heart attacks and heart-related deaths. Warnings were added to its label, and the American Diabetes Association told patients to avoid using it until safety questions were resolved.

The FDA and Congress have held meetings on the drug but it has remained on the market, still used by hundreds of thousands of Americans.

Avandia’s maker, the British company GlaxoSmithKline PLC, maintains that its drug is safe. A spokeswoman said the new study has limitations, and that the company looks forward to a full discussion of evidence at the FDA hearing.

The study involved 227,571 Medicare patients, average age 74, who started on Actos or Avandia from July 2006 through June 2009 and were followed for three years on average.

Avandia patients were 27 percent more likely to suffer strokes, 25 percent more likely to develop heart failure and 14 percent more likely to die than those on Actos, researchers found.

There were 2,593 heart attacks, heart failure cases, strokes and deaths among the 67,593 Avandia users, and 5,386 of those problems among the 159,978 people taking Actos. Just dividing these numbers to compare side effect rates can’t be done, though, because people were on the drugs for differing lengths of time.

Unlike studies in younger patients that implicated Avandia, heart attack risks were similar in both groups in the Medicare study. Sudden cardiac deaths are much more common in older adults, and whether Avandia affects heart risks differently in older versus younger patients is unknown, the researchers note.

The findings suggest that if 60 people were treated with Avandia for one year, one extra case of heart failure, stroke or death would occur that could have been avoided if they’d taken Actos instead, Graham said.

“The evidence is overwhelming,” he said. “There is not a single study where those two drugs are compared where Avandia doesn’t look worse than Actos. How many studies do you have to do before you come to your senses?”

The study was observational, with the researchers examining data on patients whose doctors had prescribed Avandia or Actos. That’s less rigorous than studies that randomly assign patients to take different drugs, and therefore cannot prove that the drug is riskier.

But Dr. Alvin Powers, a diabetes specialist at Vanderbilt University, called it “important information that’s consistent with prior studies,” even if it is not definitive. He said he doesn’t prescribe Avandia because of uncertainty over its safety.

Another AMA journal, Archives of Internal Medicine, on Monday released online an expanded analysis by the same authors who did the original one in 2007; both suggest higher heart risks for Avandia.

At its hearing next month, the FDA plans to examine the latest safety data and air internal disagreement among its scientists over what should be done.

At the FDA’s request, Glaxo began a big study last year comparing heart and stroke risks in patients on Avandia or Actos, made by Japan’s Takeda Pharmaceuticals. It aims to enroll thousands of patients, but an editorial in JAMA about the Medicare study says it would be unethical to let the study continue.

The editorial, by Dr. David Juurlink of the University of Toronto, says it is hard to understand why patients and doctors would choose Avandia when a safer alternative exists. He led a previous study of elderly diabetics in Ontario that also found higher risks with Avandia versus Actos.

Technorati Tags: Actos, Actos side effects, Avandia, Avandia side effects, diabetes 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

A pink pill designed to boost sex drive in women — the latest attempt by the drug industry to find a female equivalent to Viagra — fell short in two studies, federal health regulators said Wednesday.

The Food and Drug Administration is considering Boehringer Ingelheim’s drug flibanserin for premenopausal women who report a lack of sexual desire, a market that drugmakers have been targeting for more than a decade since the blockbuster success of Viagra in men.

The search for so-called “female Viagra,” has proved elusive though, with many drugs abandoned after showing lackluster results.

On Friday the FDA will ask a panel of experts to weigh in on the safety and effectiveness of Boehringer’s drug. The agency is not required to follow the group’s advice, though it often does.

In its review posted online, the FDA said two Boehringer studies failed to show a significant increase in sexual desire, as recorded by women in a daily journal. Women taking the drug reported slightly more sexually satisfying experiences, but FDA said that was not the primary measure of the study.

“The division wanted to see that an effect of treatment is an overall increase in sexual desire regardless of whether a sexual event occurred or not,” states the FDA review.

The FDA also noted increased side effects like depression, fainting and dizziness seen among women taking the pink pill.

The drug, which is related to the antidepressant family, affects serotonin and several other brain chemicals, though it’s not clear how that increases sex drive.

“We don’t know specifically what the exact mechanism of action is but we believe it acts on brain chemicals that have a role in human sexual response,” said Dr. Peter Piliero, executive director for Boehringer’s U.S. medical affairs.

Since the launch of Viagra in 1998, more than two dozen experimental therapies have been studied for so-called “female sexual dysfunction,” a market which some analysts estimate at $2 billion.

Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York, says arousal in women is so complicated that it may be unrealistic to expect a pill to completely address sexual problems.

“It’s a fairly complicated area, unlike in men’s sexual dysfunction where there’s a major mechanical concern,” said Kavaler. “In women there’s no mechanical concern, so if she’s not having a successful sex life, where is the problem?”

Pharmaceutical approaches to boosting female libido have evolved over time. Initially, most treatments aimed to increase blood flow to the genitals, similar to Viagra. A second wave of would-be blockbusters focused on boosting hormones, including testosterone, which is linked to sexual interest. Flibanserin is the first drug to approach the problem through brain chemistry.

The FDA has approved an unusual handheld vacuum device that increases blood flow to the clitoris to increase sexual arousal. But all drug therapies have fallen short so far.

In 2004, Pfizer halted its study of Viagra in women due to inconclusive results. Later that year an FDA panel rejected Procter & Gamble’s testosterone patch Intrinsa, due to potential risks of heart disease and cancer. Smaller companies are currently developing creams and nasal sprays to increase female libido.

BioSante Pharmaceuticals Inc. expects to submit its testosterone gel LibiGel for FDA approval next year.

Medical surveys have estimated more than 40 percent of women suffer from some form of sexual dysfunction; Boehringer estimates as many as one in 10 women could be helped by its drug.

Boehringer tried to zero in on the chemical aspect of sexual dysfunction by only testing its drug on premenopausal women who were in stable relationships and not taking other medications. Despite wanting to have a sexual relationship, the women enrolled in company studies reported a persistent lack of desire that caused them “distress or interpersonal difficulty.”

Leonore Tiefer, a psychiatry professor at New York University who runs a private sex therapy practice, believes drugmakers have oversimplified female sexuality. She says in most cases lack of sex drive has more to do with the quality of one’s relationship and lifestyle than brain chemicals.

During the public comment period at Friday’s meeting, Tiefer will ask the FDA to reject flibanserin, arguing it offers meager benefits for women with unknown long-term risks.

The modest results reported by Boehringer have also cooled Wall Street’s expectations for the drug.

Decision Resources analyst Alasdair Milton said he expects flibanserin sales to peak at $300 million after six or more years on the market. By comparison, male sexual dysfunction drugs including Viagra, Cialis and others posted combined sales of $4.4 billion last year, according to health care data firm IMS Health.

Privately-held Boehringer Ingelheim posted sales of $12 billion last year. The Ingelheim, Germany -based company makes a range of prescription drugs for heart disease, HIV and other diseases.

Technorati Tags: BioSante Pharmaceuticals, Boehringer, female sexual dysfunction, female viagra, pink pill, prescription drugs, Viagra

Swiss drugmaker Novartis AG won wider U.S. approval for its leukemia drug Tasigna to treat a rare form of the blood cancer at an earlier stage of the disease, the Food and Drug Administration said on Thursday.

Tasigna had previously been approved to treat adults with chronic myeloid leukemia, or CML, in patients who could not tolerate or were no longer responding to treatment with Gleevec, an older but highly effective Novartis drug.

The new approval could lead to significantly higher sales of Tasigna, known chemically as nilotinib.

In a clinical study presented at a major cancer meeting earlier this month, Tasigna fared better than Gleevec in a head-to-head trial, paving the way for the expanded approval.

About 44 percent of patients taking the newer Novartis pill had a major molecular response compared with 22 percent for Gleevec after 12 months.

A major molecular response is defined by a reduction of disease by 99.9 percent and has been associated with higher rates of long-term survival.

The side effects, or toxicity, seen with Tasigna were less severe than with Gleevec in the head-to-head study, researchers said when presenting the data.

Both Tasigna and Gleevec belong to a class of drugs called tyrosine kinase inhibitors, which deactivate messages that make leukemia cells malignant and kills them.

Bristol-Myers Squibb Co is hoping to win earlier stage approval for its similar CML drug Sprycel, which also topped Gleevec in a recent head-to-head trial.

Any long-term survival improvement the newer drugs can demonstrate over Gleevec would be impressive. The older drug increased the CML 10-year survival rate from less than 20 percent to up to 90 percent and transformed CML from a death sentence to a manageable disease for most patients.

“It’s important for companies to continue developing oncology drugs for earlier stages of the disease once they have demonstrated clinical effectiveness in resistant forms of cancer,” Dr Richard Pazdur, director of the Office of Oncology Drug Products for the FDA’s Center for Drug Evaluation and Research, said in a statement.

“This approach has the potential to increase the availability of an effective treatment to more patients,” he added.

(Reporting by Bill Berkrot; Editing by Tim Dobbyn)

Technorati Tags: blood cancer, Gleevec, leukemia drug, nilotinib, Novartis, oncology drugs, Tasigna

The trial of a doctor and his wife accused of contributing to the fatal overdoses of 68 patients by overprescribing pain medication went to jurors on Tuesday.

Stephen Schneider and his wife Linda were portrayed by the prosecution in closing arguments as running a “Burger King for pain pill addicts” while the defense argued that the state’s case was overblown.

It case has drawn attention in part because of a debate over the medical treatment of pain in the United States, but also the high number of deaths attributed to the defendants.

“This is a sordid tale of how money and not medicine controlled the defendants’ actions,” Assistant U.S. Attorney Tanya Treadway told jurors in closing arguments.

“The defendants were running a pill mill, not a legitimate medical practice,” she added.

But defense attorneys said the case was pushed by insurance companies who didn’t want to pay for expensive medication that Dr. Schneider prescribed to poor people.

“This is a reimbursement case for insurance, at most,” Kevin Byers, the attorney for Linda Schneider, told jurors. He said the Schneiders’ practice had been “doctored up to look like a huge, rolling death machine.”

At least one patients’ advocacy group has voiced its support for Schneider, who is no longer practicing medicine.

The Schneiders are charged in federal court with illegally prescribing narcotics, health-care fraud and money laundering. They face up to life in prison if convicted.

The indictment against the couple alleges their actions contributed to the deaths of 68 patients.

Treadway recounted testimony about many of them Tuesday, detailing how they had failed drug screening tests, required increased dosages of medication, and suffered non-fatal overdoses before finally dying.

One patient was a stripper for whom Schneider prescribed drugs to relieve performance anxiety, Treadway said.

Many died within days of their last visit to Schneider’s clinic, she said. Schneider often saw more than 50 patients in a day at the clinic, which was located in Haysville, a small town south of Wichita in south-central Kansas.

The Schneiders did not receive money for the drugs their patients took, but they fraudulently billed insurance companies and the government for patient services, using the money to buy a Hummer and a home in Mexico overlooking the Pacific Ocean, Treadway said.

Byers conceded that the volume of patients seen by the Schneiders made for a “chaotic” practice. “I’m sure there were mistakes made,” he said. “That doesn’t make it criminal or an illegal enterprise.”

Technorati Tags: medical treatment of pain, pain medication, prescribed drugs, Wichita

Substituting brown rice or another whole grain for white rice can help reduce the risk of type 2 diabetes, new research suggests.

Five or more servings of white rice a week increased the risk of type 2 diabetes by 17 percent, according to the study, which is published in the June 14 issue of the Archives of Internal Medicine. But replacing white rice with brown rice could reduce the risk of developing type 2 diabetes by 16 percent, the study found.

“This is an important message for public health. White rice is potentially harmful for the risk of type 2 diabetes,” said the study’s lead author, Dr. Qi Sun, an instructor of medicine at Harvard Medical School and a researcher at Brigham and Women’s Hospital in Boston.

“Over the last decade, rice consumption in the U.S. has really increased a lot, but more than 70 percent of the rice consumed is white rice,” said Sun, who added, “People should replace white rice with brown rice or whole grains.”

The reason that brown rice may offer some protection, according to Sun, is that it still contains many of the nutrients and fiber that are stripped away in the production of white rice. During the refining and milling process necessary to make white rice, the rice loses a significant amount of its fiber and most of the vitamins and minerals, according to the study.

“When you have just the white rice, it’s mostly protein and starch, and you’re making freer carbohydrates that are easy to digest,” said Dr. Jacob Warman, chief of endocrinology at the Brooklyn Hospital Center in New York City.

“With white rice, the digestive enzymes can more easily penetrate the rice grains and release the starch for digestion. After ingesting white rice, blood sugar increases more rapidly,” Sun said.

To analyze how those differences affect the body over the long term, Sun and his colleagues culled data from three different studies involving nearly 200,000 participants. The studies (Health Professionals Follow-up Study and the Nurses’ Health Study I and II) included 39,765 men and 157,463 women, and contained detailed data on dietary intake that was updated every four years over a 14- to 22-year follow-up.

After adjusting the data to control for many other factors that could contribute to type 2 diabetes — such as body mass index, family history, age and other dietary habits — the researchers found that the consumption of white rice was associated with an increased risk of developing type 2 diabetes, while regular consumption of brown rice was linked to a reduced risk.

People who ate at least five servings of white rice a week had a 17 percent increased risk of type 2 diabetes, while those who ate at least two servings of brown rice a week reduced their risk of type 2 diabetes by 11 percent.

The researchers estimate that if people replaced white rice with brown rice, the risk of type 2 diabetes would go down by 16 percent.

One problem Sun and his colleagues discovered while doing the study was that brown rice consumption was relatively low during the study period. It’s only in recent years that brown rice is becoming more popular. So, the researchers also evaluated the effect that replacing white rice with whole grains would have and found that the risk of diabetes would be 36 percent lower.

“There was a very strong association between whole grains and a decreased risk of type 2 diabetes. We recommend replacing white rice with brown rice or other whole grains,” said Sun.

“In general, bulking up on grains is a good idea, and this — switching to brown rice from white — is such an easy substitution to make,” said Warman.

Technorati Tags: brown rice, Diabetes Prevention, type 2 diabetes

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

The head of the World Health Organization said Tuesday that her decisions about swine flu were not influenced by advisers’ links to pharmaceutical companies, which were pointed out in a critical journal article this month.

The article last week in the BMJ, formerly known as the British Medical Journal, pointed out that WHO did not disclose potential conflicts of interest among some of the experts involved in writing guidelines for pandemic flu preparations. Three scientists out of 22 who worked on the guidelines were named as having received some money from pharmaceuticals. The scientists did not work at the drug companies, but were paid for things like speaking at meetings sponsored by them.

The guidelines recommend, among other things, that countries consider buying antivirals and vaccines to combat a pandemic.

The authors of the BMJ article suggest, without providing direct evidence, that these scientists’ ties to pharmaceutical companies influenced WHO’s recommendation that countries buy drugs and vaccines — adding to those drug companies’ profits.

“Our investigation has revealed damaging issues,” wrote Deborah Cohen of BMJ and journalist Philip Carter. “These conflicts of interest have never been disclosed by WHO.”

WHO’s handling of the outbreak is being reviewed by a 29-member expert panel that will report its findings next year. Critics say many of those panelists are also trusted WHO advisers and government employees who could end up whitewashing any failures.

“At no time, not for one second, did commercial interests enter my decision-making,” WHO Director-General Margaret Chan said.

Chan insisted she was open to the panel’s criticism. “Should this committee decide that the current definition of a pandemic and the phases leading up to its declaration need to be tightened or otherwise revised, this will be another recommendation that we will welcome, and act on.”

The U.S. Health and Human Services department defended the U.N. body.

“WHO handled the outbreak in a very measured and appropriate manner,” said Bill Hall, an HHS spokesman. “Their decisions were driven by the existing and evolving conditions at the time.” He said there was “no indication whatsoever that any of their decisions were influenced by industry.”

Other leading officials agreed.

“There was nothing in those guidelines that was not based on the best science available,” said Michael Osterholm, a flu expert at the University of Minnesota who has advised the U.S. on pandemic preparations. He said the scientists consulted were the world’s top flu experts and to not include them would have been a major flaw.

Osterholm said that because flu viruses are unpredictable, it was impossible for anyone to predict last spring that swine flu would not evolve into a more lethal strain.

He slammed the BMJ article, calling it “irresponsible and reckless,” and said its authors had not substantiated their claims WHO behaved inappropriately during the pandemic. “It’s akin to shouting ‘fire’ in a crowded theatre without regard to the consequences,” Osterholm said.

He said while WHO should be subjected to the highest scrutiny, BMJ’s accusations had done “untold damage to the public health infrastructure of the world.”

Harvey Fineberg, the president of the Institute of Medicine in Washington, said the review panel which he heads will hear from critics of WHO when it next meets from June 30 to July 2.

A report published by the Council of Europe last week said the guidelines from WHO, European Union agencies and national governments led to a “waste of large sums of public money and unjustified scares and fears about the health risks faced by the European public.” The agency is not an EU body.

Technorati Tags: drug companies, Flu, flu viruses, pharmaceutical, WHO

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