Physician-pharmacist teams may help increase hypertension control.

Physician-pharmacist teams may help increase hypertension control.

HealthDay (11/23, Edelson) reported that, according to a study published in the Nov. 23 issue of the Archives of Internal Medicine, hypertension "is better controlled by doctor-pharmacist teams working hand-in-hand than by doctors and pharmacists working alone." Researchers from the University of Iowa College of Pharmacy divided "402 people treated for high blood pressure at six clinics...into two groups."

Medscape (11/23, Barclay, subscription required) reported that patients at "three clinics were randomly assigned to a control group," while patients at the other three "clinics were randomly assigned to an intervention group in which physicians and pharmacists underwent team-building exercises." Next, "using national guidelines, clinical pharmacists made drug therapy recommendations to physicians in the intervention group." The investigators discovered that "in the control group, mean guideline adherence scores increased from 49.4 ± 19.3 at baseline to 53.4 ± 18.1 at six months (8.1% increase), compared with a 55.4% increase in the intervention group (from 40.4 ± 22.6 at baseline to 62.8 ± 13.5 at six months)."

MedPage Today (11/23, Phend) reported, "These results suggest that clinics and health systems with clinical pharmacists consider giving them a more direct role in patient management," the authors said. An editorial accompanying the study pointed out that "so far, the medical home model for chronic conditions such as hypertension typically hasn't included a pharmacist," but "before the medical home" concept "takes further root, comprehensive efforts should be made to ensure that pharmacists are included on the team because of the mounting evidence for their contribution to quality of care."

FDA

FDA approves Crestor for younger patients with familial hypercholesterolemia.The AP (10/16) reported that "the Food and Drug Administration approved AstraZeneca PLC's cholesterol drug Crestor [rosuvastatin] for use by children and teenagers with a genetic disease" called heterozygous familial hypercholesterolemia. The condition "affects 10 million people worldwide, and causes high levels of...LDL cholesterol." HeartWire (10/16, O'Riordan) reported that "the approval is based on data from the Pediatric Lipid Reduction Trial of Rosuvastatin (PLUTO), a 12-week randomized, controlled trial that examined the safety and efficacy of rosuvastatin in 177 pediatric familial hypercholesterolemia patients."

Technology

Number of people using Internet to research drug information doubles.

Healthcare IT News (10/2, Monegain) reported, "Since 2005, the number of patients using the Internet to research prescription drug information has doubled to 102.3 million, according to a new study from Manhattan Research." The survey of 8,600 adults "during the third quarter of this year" also "found that the major theme of the digital health landscape over the past four years is the increasing diversity of the overall patient media mix." In addition, health-related "social media, in particular, has flourished in recent years with the increased popularity of online patient communities, social networking and health 2.0 applications."

Johnson & Johnson recalls 57 lots of pediatric Tylenol products.

Johnson & Johnson recalls 57 lots of pediatric Tylenol products.

The AP (9/25) reports that on Sept. 24, "Johnson & Johnson's McNeil unit" announced that "it is voluntarily recalling 57 lots of infants' and children's liquid Tylenol [acetaminophen] products because of possible bacterial contamination." All of the "products being recalled were made between April and June" 2008 "and include nearly two dozen varieties, including Children's Tylenol Suspension 4 oz. Grape, Infants' Tylenol Grape Suspension Drops 1/4 oz., and Children's Tylenol Plus Cold/Allergy 4 oz. Bubble Gum."

The Dow Jones Newswire (9/25, Favole, subscription required) reports that, according to Johnson & Johnson, the company agreed to recall the medicines after consulting with the Food and Drug Administration, even though the possibility of medical harm is slim.

The Los Angeles Times (9/24, Dennis) "Booster Shots" blog reported that the recall was implemented "because examination of bulk raw material detected that one of the inactive ingredients did not meet internal testing requirements. Specifically, the gram-negative bacteria Burkholderia cepacia (B. cepacia) was detected." Even though "the portion of raw material in which the bacteria was found was...not used in the production of any finished product," the manufacturer decided to "recall all product that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria."

WebMD (9/24, Hitti) reported that in a recall letter dated Sept. 18, McNeil Consumer Healthcare stated, "Adverse health consequences of B. cepacia infections could be potentially severe, especially in high-risk patients, such as those with underlying pulmonary disease, cystic fibrosis, or compromised immune systems." MedPage Today (9/24, Peck) and Florida's Palm Beach Post(9/24, Isger) also covered the story.

Consumption of alcohol may interfere with controlled-release drugs, study suggests.

MedPage Today (9/24, Fiore) reported that, according to a study published online in the journal Molecular Pharmaceutics, "consumption of alcohol may interfere with controlled-release drugs, potentially sending an excess of active ingredient into the bloodstream." After conducting a meta-analysis, researchers found that "ethanol tended to impair the release mechanism, sending the drug more quickly into the small intestine" -- a "particularly worrisome" finding "in the case of controlled-release opioids."

Experimental AIDS vaccine shows unexpected efficacy in trial.

Experimental AIDS vaccine shows unexpected efficacy in trial.

The Washington Post (9/24, Brown) reports, "An experiment in Thailand involving 16,000 men and women has demonstrated for the first time a small but measurable protective effect of an AIDS vaccine." The Post calls the results "barely significant on statistical grounds, perplexing for scientific reasons and unanticipated by most researchers. Nevertheless, the first positive results for an AIDS vaccine after two decades of experimentation was being called a milestone."

"I don't want to use a word like 'breakthrough,' but I don't think there's any doubt that this is a very important result," Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), told the New York Times (9/24, McNeil). The vaccine, known as RV 144, "protected too few people to be declared an unqualified success. And the researchers do not know why it worked."

The AP (9/24, Marchione, Casey) reports, that "the vaccine cut the risk of becoming infected with HIV by more than 31 percent." It is a combination of Sanofi Pasteur's ALVAC "and AIDSVAX, originally developed by VaxGen Inc." The vaccine was tested "in a 'prime-boost' approach, where the first one primes the immune system to attack HIV and the second one strengthens the response."

The US Army funded the study along with the NIAID and the NIH, Bloomberg News (9/24, Bennett) adds. For the study, "researchers enrolled volunteers in Thailand's Chon Buri and Rayong provinces, which have the nation's highest rates of HIV." Volunteers "were given four doses of the ALVAC vaccine and two of the AIDSVAX shot over six months, then monitored for three years. They were also given advice on safe sex."

Researcher Dr. Jerome Kim, a US Army colonel at the Walter Reed Army Institute of Research, said, "We had 74 infections in the placebo group and 51 in the vaccine group," Reuters (9/24, Fox) reports. Dr. Fauci admitted that he "did not think there was a very high chance that this would give any degree of efficacy." Dr. Fauci added that "nonetheless, we went ahead with the trial and it was controversial to go ahead with it."

Shortage of Tamiflu seen nationwide.

FDA confirms three new cases of PML linked to Tysabri.

The AP (9/22) reported that the FDA "says it confirmed three new cases of a potentially lethal brain inflammation linked to the multiple sclerosis drug Tysabri [natalizumab]." The reports "are the first confirmed new cases since June," and since mid-2006, there "have been 13 reported cases of progressive multifocal leukoencephalopathy, or PML." The AP adds that "the FDA says the risk appears to increase as patients remain on Tysabri" and all "the PML cases are linked to its use in multiple sclerosis."

The Wall Street Journal (9/23, Armstrong) also reports on how the cases of PML will affect Biogen Idec Inc., the maker of Tysabri, and its stock.

Shortage of Tamiflu seen nationwide.

The Tennessean (9/23, Sanchez) reports, "Public demand for" Tamiflu (oseltamivir) "has caused a shortage of the children's dosage" nationwide, and some pharmacies "have run out of Tamiflu in the liquid form." The Tennessean notes, "Until more liquid prescription can be manufactured, pharmacists must convert the adult dosage capsules into a liquid by following FDA-approved guidelines on mixing." Meanwhile, health officials "are concerned that if more liquid is not commercially made soon, the items needed for the makeshift version also could run short."

Study suggest lack of health coverage contributes to 45,000 deaths annually.

Study suggests lack of health coverage contributes to 45,000 deaths annually.The CBS Evening News (9/17, story 7, 2:20, Couric) reported, "While the debate goes on over the cost of insuring everyone, a new study reveals the cost of not doing it." Harvard investigator Steffie Woolhandler, MD, MPH, was shown saying, "We found that 45,000 Americans are dying annually due to lack of health insurance." According to the Boston Globe (9/18, Cooney), "researchers from Cambridge Health Alliance reported yesterday in the American Journal of Public Health on a study that followed 9,005 adults under 65 years old" who took part in a national CDC survey "from 1986 through 1994. After 12 years, 351 people had died. Sixty of them were uninsured, and 291 were insured." MedPage Today (9/17, Walker) explained that the researchers adjusted for such factors as "obesity, exercise habits, alcohol use, and smoking status"; and determined that "those without insurance were 40-percent more likely to die than those with a private insurance plan." Among the other factors that increased the risk of death were "clinically verified poor health (222 percent), smoking (102 percent), being a former smoker (42 percent), and being a male (40 percent)." The New Mexico Business Weekly (9/17) pointed out that the study "disputes a previous one conducted by the Institute of Medicine (IOM), which, in 2002, estimated that some 18,000 Americans between the ages of 25 and 64 died each year because of a lack of health insurance." The New York Times (9/17, Abelson) "Prescriptions" blog noted that the study attributed the increase in risk to "at least two factors. One is the greater difficulty the uninsured have today in finding care, as public hospitals have closed or cut back on services. The other is improvements in medical care for insured people with treatable chronic conditions like high blood pressure. 'As healthcare for the insured gets better, the gap between the insured and uninsured widens,' Dr. Woolhandler said." Reuters (9/18, Heavey) provides excerpts of an interview it did with co-author Dr. David Himmelstein of Harvard. In comparing the IOM study to the new Harvard study, Himmelstein attributed the increased mortality risk to the fact that the rate of uninsured has increased by approximately 2 billion since the initial study. Meanwhile, according to HealthDay (9/18, Pallarito), the National Center for Policy Analysis (NCPA) released a statement calling the "Harvard research 'flawed.'" NCPA CEO John C. Goodman said the findings "are based on faulty methodology and the death risk is significantly overstated. The subjects were interviewed only once and the study tries to link their insurance status at that time to mortality a decade later. Yet over the period, the authors have no idea whether subjects were insured or uninsured, what kind of medical care they received, or even cause of death." Near the end of the aforementioned CBS Evening News (9/17, story 7, 2:20, Couric) clip, Goodman was shown saying, "I think you can't trust the results. Having said that, we ought to do something for the uninsured."

FDA requires boxed warning for promethazine.

FDA requires boxed warning for promethazine.

The AP (9/17, Johnson) reports, "Makers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation," according to the FDA. Regulators said that "makers of generic promethazine will have to put a [boxed] warning at the top of the detailed package insert explaining that when the drug is administered incorrectly, it can damage skin severely, including causing gangrene."

MedPage Today (9/16, Peck) reported, "The new label also warns that there is 'a risk that the drug can leach out from the vein during intravenous administration and cause serious damage to the surrounding tissue. As a result of these risks, the preferred route of administration is injecting the drug deep into the muscle.'"

Medscape (9/16, Rebelo) reported, "The FDA is also requiring a revision in the Dosage and Administration section of the drug's labeling to highlight 'specific recommendations for the maximum concentration (25 mg/mL) and rate of administration (25 mg/min) when intravenous administration of promethazine is required.'"

FDA says Tysabri linked to 13 cases of PML since 2006 re-introduction.

Bloomberg News (9/17, Larkin) reports, "Biogen Idec Inc. and Elan Plc's Tysabri [natalizumab] has been linked to 13 cases of a deadly brain disease" -- progressive multifocal leukoencephalopathy (PML) -- "since the drug was reintroduced in July 2006, regulators said." The FDA on Wednesday posted on its website new "safety information for the treatment for relapsed multiple sclerosis and Crohn's disease."

The Dow Jones Newswire (9/17, Gryta, subscription required) adds that Tysabri's label has not changed and the FDA said that the overall rate of patients developing PML is below the one-in-1,000 rate listed on the drug's label. Still, the agency warned that the risk of PML "appears to increase with the number of Tysabri infusions received," and that 25 was the average number of infusions received before the PML diagnosis.

FDA says Allergan's Latisse website omits risk information.

The Wall Street Journal (9/17, Favole, subscription required) reports that the FDA said Allergan Inc.'s website for Latisse, its eyelash thickener, omits risk information about the product. A Sept. 10 letter to Allergan stated that the company's website lacks information about the risk of bacterial keratitis from using Latisse.

Bloomberg News (9/17, Larkin) reports that regulators said, "Materials that promote a drug's benefits must also address its risks, which in this case include allergic reactions or hair growth outside the treatment area." The FDA "ordered Allergan to reply by Sept. 24 with a plan to discontinue use of these types of promotions."

The Orange County Business Journal (9/16, Reed) reported, "Allergan said that it's working closely with the FDA to address the concerns," and that "it's no longer using an exhibit that described the evolution of lash enhancers, which drew the regulators' objections." Reuters (9/17, Richwine) also covers the story.

FDA approves four H1N1 vaccines.

FDA approves four H1N1 vaccines.

The Wall Street Journal (9/16, Dooren, Favole, subscription required) and many other news sources report that HHS Secretary Kathleen Sebelius announced Tuesday that the FDA has approved H1N1 vaccines made by Novartis AG, a unit of Sanofi-Aventis SA, CSL Ltd., and MedImmune, an AstraZeneca PLC unit.

ABC World News (9/15, story 8, 0:20, Gibson) added that "the government is aiming for a rollout by early next month, and says there should eventually be enough vaccine available for everyone."

In its lead story, CBS Evening News (9/15, lead story, 2:50, Couric) called it "the biggest immunization campaign in US history.

Sebelius announced the approvals at a hearing of the House Energy and Commerce Committee, saying that "some vaccine might arrive by the first week in October, with 'ample supplies' by mid-October," the Miami Herald (9/15, Tasker) reports. She said, "It appears that the vaccine we're producing is working quite well."

CDC director Thomas Frieden, MD, also noted the timeline, saying, "We think the first doses of some of the vaccine forms should be available in about three weeks," CNN (9/16) reports. "Previously, the CDC had been predicting the vaccine would not be available before middle or late October."

The Los Angeles Times (9/16, Maugh) adds that the US "has ordered enough vaccine for 195 million doses, meaning that 'we will have enough vaccine available for everyone,' Sebelius said." The vaccines "will be shipped to national distribution centers," USA Today(9/16, Sternberg) explains. The shots will then become available at outlets such as "public health clinics, doctors' offices, schools, pharmacies, and grocery stores" depending on the state.

NBC Nightly News (9/15, lead story, 2:40, Williams) noted, however, that due to "problems with a 1976 vaccination campaign against a different swine flu threat...Sebelius heard questions today about the safety of the new vaccine." She told Congress, "We are assured by the scientist that lots of steps have been taken along the way to make sure that this will be a safe procedure."

And according to the AP (9/16, Neergaard), Sebelius also said that physicians should not "hand out prescriptions for anti-flu medicines to be used to prevent flu... because 'it could make them sicker in the long run.'" She "stressed" that "Tamiflu and Relenza should be used for treatment only."

Apart from the four vaccines approved Tuesday, Sebelius "fully anticipate[s]" a fifth form of the vaccine to be licensed, Bloomberg News (9/16, Larkin) notes. Bloomberg adds that GlaxoSmithKline PLC is likely the manufacturer of that vaccine.

Until the approved vaccines arrive, "HHS is urging all individuals to get their seasonal flu shots now," CQ HealthBeat (9/16, Attias, subscription required) reports. CongressDaily (9/16, Kivlan, subscription required), New York's Newsday (9/16, Ricks), the South Florida Business Journal (9/16, Raubner), and the Dow Jones Newswire (9/16, Horobin) also cover the story.

Leading News in Pharmacy

Research indicates metformin combined with doxorubicin may kill breast cancer stem cells, delay recurrence.

The Wall Street Journal (9/15, Winslow, subscription required) reports that the diabetes drug metformin, when combined with chemotherapy drug doxorubicin, may shrink breast-cancer tumors and keep them from coming back more effectively than chemotherapy alone, according to a study published in the journal Cancer Research. Researchers reported that the combination treatment killed cancer stem cells in addition to regular cancer cells.

HealthDay (9/14, Gardner) noted that for the study, researchers treated "mice with breast cancer" with metformin and doxorubicin simultaneously. The mice "showed reductions in tumor size in four types of breast cancer, as well as longer remission times."

Notably, "mice treated with the combination" remained "cancer-free for four months, unlike mice treated with either drug alone," WebMD (9/14, DeNoon) reported. The researchers also noted that "metformin and standard chemotherapy" may "make each other work better," so "metformin could be used with lower doses of chemotherapy." AFP (9/14) also covered the story.

H1N1 vaccinations scheduled to begin in three weeks in US.

H1N1 vaccinations scheduled to begin in three weeks in US.

Bloomberg News (9/14, Randall, Gale) reports, "Swine flu vaccinations may begin in three weeks, earlier than previously anticipated, after the first US tests found a single shot to be effective in eight to 10 days, US health officials said. The first shots may be available by the end of this month and administered to patients the first week of October, said Nancy Cox, director of the flu division at the US Centers for Disease Control and Prevention in Atlanta." Previously, "health officials had...planned for vaccinations to begin in mid-October, requiring two shots administered three weeks apart." The piece continues to describe early outbreaks in the US, and relates the testing procedures that led authorities to determine that a single dose would be sufficient to inoculate patients.

HHS Secretary Kathleen Sebelius also said that "the nation's first round of swine flu shots could begin sooner than expected, with some vaccine available as early as the first week of October," the AP(9/14) reports. She said, "We're on track to have an ample supply rolling by the middle of October. But we may have some early vaccine as early as the first full week in October. We'll get the vaccine out the door as fast as it rolls off the production line."

Sebelius "said she is confident that an ample supply of H1N1 vaccine shots will be available to the public by mid-October," the Washington Times (9/14, Lengell) adds. Her "optimism is a shift from last month, when the government was bracing for production delays of the vaccine." This year, "flu viruses are circulating unusually early," though of the cases reported, "98 percent are from H1N1, said Dr. Anne Schuchat of the Centers for Disease Control and Prevention."

USA Today (9/14, Sternberg) notes Sebelius' comments, adding that "Nancy Cox of the Centers for Disease Control and Prevention said the first shipments will be small and reserved for priority groups such as young people and pregnant women." Cox "said evidence that one shot offers protection was a big confidence-booster that prompted the government to speed up its timetable." Bloomberg News (9/14, Murray) and Voice of America (9/14) also report on Secretary Sebelius' comments.

Study indicates peramivir may be as effective against flu as Tamiflu. The AP (9/14, Marchione) reports, "Researchers delivered a double dose of good news Sunday in the fight against flu: successful tests of what could become the first new flu medicine in a decade, and the strongest evidence yet that such drugs save lives, not just shorten illness. A single intravenous dose of the experimental drug, peramivir, cleared up flu symptoms as well as five days of Tamiflu pills did, a large study in Asia found." The piece continues to detail other research presented at an American Society for Microbiology conference in California on Sunday, including studies pointing to the lifesaving utility of Tamiflu. The conference "is the first big meeting of infectious disease specialists since the new H1N1 swine flu emerged in April. Treatment options are getting huge attention because it will take a month or more for people to get swine flu vaccine and have time to develop immunity from the shot."

Drug Approvals

FDA approves antibiotic telavancin.

Bloomberg News (9/12, Matsuyama) reported, "Theravance Inc. and Astella Pharma Inc. said they received US approval to market a new antibiotic for hard-to-treat skin infections such as methicillin-resistant Staphylococcus aureus, or MRSA." The FDA approved telavancin as "a once-daily infusion," which will "be sold as Vibativ."

The San Francisco Business Times (9/13, Leuty) reported that the approval includes "a 'black box' warning for pregnant women." The FDA sought "more data" from Theravance "even after an advisory committee late last year signed off on telavancin" because MRSA "has become increasingly resistant to generic vancomycin." Reuters (9/14, Nishitani) also covers the story.

FDA approves diabetic insulin spray for IND program.

MedPage Today (9/11, Petrochko) reported, "The FDA has approved Oral-lyn, an insulin spray treatment for type I and type II diabetes, for its Investigational New Drug program." The spray "delivers prandial insulin orally through a device similar to an asthma inhaler, which sprays it on the inside of the cheek." MedPage added, "Researchers have spent much time looking for alternative means of dispensing insulin to diabetics, and the IND program allows patients with serious or life-threatening conditions, and without suitable alternative treatment, to access drugs otherwise available only to those in a clinical trial."

Clinical trials suggest only one H1N1 vaccine dose may be needed in adults.

ABC World News (9/10, story 4, 2:10, Besser) reported that the New England Journal of Medicine...published results of a vaccine trial out of Australia" of "the new swine flu vaccine and it was done in adults. And what they found was that one dose of the vaccine was enough to give protective immunity." Previously, federal researchers "were saying you might need two," the CBS Evening News (9/10, story 6, 0:15, Couric) reported. The vaccine is expected to be ready by mid-October."

On its front page, the New York Times (9/11, A1, McNeil) reports that the results indicate "the vaccine supplies now being made will go twice as far as had been predicted," which means it may be possible to vaccinate "all the 159 million people that the Centers for Disease Control and Prevention estimate are in the high-risk groups." The first trials involved "a single 15-microgram dose in adults" and were conducted by CSL Limited, an Australian firm. CSL "is under contract to supply millions of doses to the United States government." Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, "said trials now under way under the sponsorship of the National Institutes of Health were showing that adults who got only a single dose were protected within 8 to 10 days, which he said 'corroborates and confirms the exciting data' reported in the Australian study."

The AP (9/11, Neergaard) reports that "scientists had feared that people of all ages would need two shots about a month apart because the new H1N1 strain is so genetically different from normally circulating flu strains that most of the population has little if any immunity."

The Washington Post (9/11, A3, Stein) adds that the "eagerly awaited findings mark the first results from a flurry of studies that scientists have been rushing to conduct to develop a swine flu vaccine. The findings indicate that plans to inoculate millions of Americans...and others worldwide could occur much more quickly and require far less vaccine than officials had feared." Dr. Fauci noted that if two doses were needed, "that would be a major strain on vaccine supplies nationally and globally." HHS plans to "release preliminary results Friday of its vaccine studies." Fauci said NIH's findings "are consistent with the Australian study involving 240 patients and show the response occurs even more quickly -- eight to 10 days -- than the 21 days that study found."

USA Today (9/11, Sternberg) reports that the Australian study "showed that nearly 97 percent of volunteers given a standard dose of the vaccine produced antibody levels that typically protect against flu infection, giving planners the welcome news that they may need less vaccine to save more lives." CNN (9/11) and Bloomberg News (9/11, Randall) also cover the story.

ACTION ALERT

September 10, 2009

Action Needed: Urge Congress to Support Pharmacist Clinical Services

Dear Viewers:

We need your help today. Congress returned to Washington, DC this week and health care reform is on the docket. To find savings and help fund reforms, as the House merges its bills (from the Education and Labor, Energy and Commerce, and Ways and Means committees) and as the Senate merges its bills (from the Health, Education, Labor and Pensions, and Senate Finance committees), we anticipate that Members of Congress will cut programs from the current health care reform (HCR) proposals. We do not want to be among the cuts.

Regardless of how Congress decides to expand or fund access to the health care system, we must take advantage of this opportunity to improve the quality of care and lower health care costs by improving patient access to pharmacist clinical services. It is a critical time for pharmacy to demonstrate its support for the pharmacy-related provisions in the health care reform proposals.

The Issues

While APhA supports several provisions in each proposal, we are focused on three priorities that improve patient access to pharmacist clinical services that are included in the House

Tri-Committee, House Energy & Commerce (E&C) Committee, and the Senate Health, Education, Labor and Pensions (HELP) Committee proposals. These provisions would:

• Include Pharmacists as Part of Integrated Care Models (House Tri-Committee Section 1301; Senate HELP Section 212);
• Include Pharmacists in Payment for Transitional Care Activities (House Tri-Committee Section 1151; Senate HELP Section 216); and
• Conduct a Medication Therapy Pilot (House E&C: Congressman Butterfield (D-NC) Amendment; Senate HELP Section 213)

The Action

Make your voice heard in this critical debate that affects the future of the profession. Please take a moment to contact your Members of Congress and express your support for pharmacist clinical services as a part of any health care reform proposal.

Take Action Now

Thank you in advance for your support.

Surgeon goes crazy and cuts off patient's penis and slices it into three pieces

A surgeon in Romania suddenly went crazy and cut off a patient's penis and sliced it into three pieces. He was supposed to have operated on the man's testicles.

The doctor, Naum Ciomu, was a senior doctor and also worked at the University teaching anatomy.

Head of Bucharest's emergency hospital, Sorin Oprescu, said "We are shocked by what has happened. It is the first time we have had such a case."

The patient had a testicular malformation and was being operated on by Dr. Ciomu. The patient was rushed for emergency reconstructive surgery.

The plastic surgeon who is trying to restore the patient's organ said he may be able to restore his urinary function, but doubts whether the man's penis will ever be able to perform sexually.

The patient's wife is suing the doctor.

Td

Right now we screen for Td in triage if there is an open cut or burn. If they have not had Td in the past 5 years we re-vaccinate. If the patient is male we give Adacel if no documented TdaP was given previously. If female and we have a negative preg test we give Adacel, otherwise we give Td. These policies only apply to patients > 18yo.

Angela Cortese PharmD

Two newly discovered HIV antibodies may bolster vaccine efforts, scientists say.

Two newly discovered HIV antibodies may bolster vaccine efforts, scientists say.

The Los Angeles Times (9/4, Maugh) reports, "After nearly two decades of futile searching for a vaccine against the AIDS virus," scientists at the Scripps Research Institute "are reporting the tantalizing discovery of antibodies that can prevent the virus from multiplying in the body and producing severe disease." Interestingly, the broadly neutralizing antibodies, or bNAbs, "target a portion of HIV that researchers had not considered" during prior experiments, according to the paper published online in Science. What's more, the target "is a relatively stable portion of the virus that does not participate in the extensive mutations that have made HIV able to escape from antiviral drugs and previous experimental vaccines."

The scientific community has been diligent in its vaccine quest, according to the Wall Street Journal (9/4, Naik, subscription required). Since 1987, researchers throughout the world have had a hand in nearly 100 trials, but they were thwarted in every single one. The biggest setback came in 2007 when a Merck trial yielded an experimental vaccine that actually seemed to increase the risk of infection. Accordingly, funding began drying up, as evidenced by a 10 percent decrease in annual investments in 2008.

One New York-based nonprofit remained undeterred, however. In 2006, Bloomberg News (9/4, Waters) reports, the International AIDS Vaccine Initiative "kicked off an effort dubbed Protocol G, aimed at searching for antibodies that can neutralize the strains of HIV that circulate in the developing world, where the majority of new infections are taking place." Working alongside "doctors and clinics in Thailand, Australia, the US, the UK, and especially Africa, where two-thirds of the world's infected people live, the group collected blood samples from 1,800 people who had been infected with HIV for at least three years without developing symptoms."

Using the "latest biological and computational screening techniques, which emerged from genome-sequencing technologies," investigators screened the "virus-laden samples against B cells to see how many of the HIV strains the immune cells would recognize," Time (9/3, Park) reported. "To their surprise, the B cells were able to neutralize a fair number of the viruses, but two of the antibodies produced by the cells clearly stood out as more potent than the rest" -- PG9 and PG16.

The "two new bNAbs...seem to be different for" a few reasons, the San Diego Tribune (9/3, LaFee) pointed out. Most notably, they "were isolated from...donors in developing countries where HIV is most active." They also "appear to attack a part of the HIV virus that doesn't mutate much, if at all." Lead investigator Dennis Burton said, "It looks like (they) target a particular region on the tops of these surface spikes that stud the viral surface." And, "these spikes are important to the virus because it uses them to interact with or bind to target cells." Simply put, these "antibody-vulnerable areas of the spikes may be the virus' Achilles heel." HealthDay (9/3, Mundell) and Reuters (9/4, Fox) also covered the story.

Drug Approvals

FDA approves guanfacine for AD/HD in children, adolescents.

The Philadelphia Business Journal (9/3, George) reported, "The Food and Drug Administration granted marketing approval Thursday to Shire for Intuniv [guanfacine], a nonstimulant treatment for attention-deficit hyperactivity disorder in children and adolescents aged six to 17." Shire "already has three other ADHD treatments in the United States and two AD/HD medicines outside the United States."

HealthDay (9/3, Roberts) reported that Shire said its "once-daily drug, to be available in 1-to-4 mg. strengths, is expected on pharmacy shelves in November." Reuters (9/4) also covered the story.

Quality and Safety

Single-dose swine flu vaccines raise efficacy questions.

Bloomberg News (9/4, Randall) reports, "Americans may need two vaccine doses instead of one to be immunized against swine flu because officials plan to exclude ingredients used to boost immune responses in shots made by Novartis AG and GlaxoSmithKline Plc." Novartis yesterday said "a single dose of its vaccine, which relies on a shot-boosting ingredient known as an adjuvant, safely provoked a strong immune response in a trial of 100 healthy volunteers." However, Frieden said the "formulation favored by the US doesn't use an adjuvant, and a second vaccine dose is more likely to be required." Bloomberg adds that "adjuvants are controversial because some studies show they cause immune disorders in mice."

According to the AP (9/3), it's unclear what the Novartis trial "would mean for the global swine flu supply," since the Novartis "vaccine was made using cell culture, while about 90 percent of the world's flu vaccines are made using chicken eggs." But the Wall Street Journal (9/4, Bart, subscription required) notes that the cell-based production method that Novartis uses is faster than the egg-based method.

Regulatory

Judge rules Elan-J&J deal breaches Tysabri contract with Biogen.

The Wall Street Journal (9/4, B4, Gryta, subscription required) reports that a US judge ruled that a deal between Elan PLC and Johnson & Johnson breaches a contract with Biogen Idec Inc. over the multiple sclerosis treatment Tysabri [natalizumab]. At issue is J&J's July agreement to purchase 18.4 percent of Elan.

"Biogen and Elan have an agreement that if one is acquired, the other has an option to buy its rights to Tysabri," the Boston Globe/Bloomberg News (9/4, Weidlich) reports. Under the J&J deal, therefore, "Elan assigned its right to J&J in the event that Biogen were ever acquired," Biogen argued. The judge said that "it appears to the court that Elan has designated an obligation it has to [J&J] by taking direction from [J&J] on the purchase-price negotiations." Although "no assignment of rights took place, 'it would seem there has been a breach of the Biogen-Elan collaboration agreement,'" the judge ruled. Elan was given "23 days to fix the breach." Reuters (9/4) also covers the story.

Report indicates most drugmakers meeting federal requirements for post-marketing studies.

The Dow Jones Newswire (9/4, Favole) reports, "Drug and biologics makers are generally keeping up with federal requirements to conduct studies after the Food and Drug Administration approves a medicine," according to a report from consulting firm Booz Allen Hamilton. The "review of more than 1,500 open post-marketing reviews" showed that over "89 percent of the studies are either meeting established deadlines, have been submitted to FDA for review, or have already been completed." In 2007, "Congress gave the FDA new authority...to require companies to continue studying and testing a medicine after it has been approved when health officials have lingering questions about the product's effectiveness or safety."

MedPage Today (9/3, Gever) reported that the review found "more than 750 studies -- nearly half of the 1,531 in the agency's backlog as of 2007 -- were erroneously listed as 'pending,' meaning they had not begun." But, "the agency has since acted on more than 200 post-marketing studies submitted by drug firms that had languished at the agency," of which "the overwhelming majority satisfied the agency's requirements." In fact, "only 211 remained" pending "after the audit." Reuters (9/4) also covers the story.

Technology

Grants allocated for technology-based programs to reduce medication nonadherence.

Healthcare IT News (9/3, Monegain) reported, "The Center for Technology and Aging has released guidelines for a $500,000 grants program aimed at using technology to help reduce patients' failure to adhere to prescribed medication regimens." The Medication Optimization Diffusion Grants Program "provides up to six one-year grants to organizations successfully proposing programs that directly benefit older adults," and four "or five grants will focus on Californians, while one or two may be awarded to other regions of the country." The center said that drug-related hospitalizations "cost $47 billion annually."

Obama plans detailed healthcare address as White House seeks Sen. Snowe's backing.

The Washington Post (9/4, A4, Kornblut) reports that "administration officials promised" that the President will next week "deliver a detailed prescription for reform despite the risks of spelling out exactly where he stands." Vice President Biden said the speech "will map out 'in understandable, clear terms what our administration wants to happen with regard to healthcare, and what we are going to push for specifically.'" Senior administration officials said the speech "will satisfy demands" that Obama "clarify which provisions he supports and which he could jettison. The contents of the speech are largely decided, officials said." The Post also reports the White House is focusing on winning the support of Sen. Olympia Snowe (R-ME), "who they view as the Republican most willing to reach an agreement with the White House. On Thursday, aides to Snowe confirmed that the senator is talking with administration officials, particularly with regard to her 'safety-net fallback option.'" That plan would have the government "sponsor a nonprofit insurance plan but it would become available only in states or regions where private insurance firms had failed to offer a reasonably priced product that would be affordable to 95 percent of the population."

Health Business

Dainippon seeks to tap US drug market with Sepracor purchase.

The New York Times (9/4, B4, Nicholson) reports, "Dainippon Sumitomo Pharma of Japan said Thursday that it would buy the American drugmaker Sepracor for $2.6 billion, as it seeks to tap sales in the United States and increase the products in its pipeline." Sepracor's board unanimously approved the acquisition, and will "be made with a cash tender offer for Sepracor common shares valued at $23 each, or more than 25 percent above their closing price Monday." The Times notes, "Japan's pharmaceutical industry has been especially ambitious in the United States."

The AP (9/4) also reports, "The Japanese drugmaker said the deal will give it access to Sepracor's established sales network of about 1,325 people in the US, which will help it establish a sales platform for lurasidone, a potential treatment for schizophrenia that is now in late-stage trials." Dainippon pointed out "that the acquisition of Sepracor will also increase its overseas revenue to 40 percent of its total."

The Boston Globe (9/4, Wallack) also notes that Sepracor "vowed to maintain" its Massachusetts operations. The Wall Street Journal (9/4, M12, Simms, subscription required), the Boston Business Journal (9/3, Donnelly), Modern Healthcare (9/3, Evans, subscription required), and the Chicago Tribune (9/4) also covered the story.

Bayer to pay Algeta as much as $800 million for Alpharadin.

Bloomberg News (9/4, Von Schaper) reports, "Bayer AG agreed to pay Algeta ASA as much as $800 million for the rights to an experimental cancer medicine known as Alpharadin [radium-223]." The companies will "jointly develop the medicine," and Algeta "will get $61 million in cash, as well as development and sales payments tied to the drug's success." Bayer also said the drug, which is in a Phase III clinical trial, is being tested on patients whose prostate cancer has spread to the bone and "may also battle several forms of cancer that have spread to the bone."

Forest Laboratories paid Minnesota physicians more than $750,000, analysis indicates.

The AP (9/3) reported that "an analysis by a nonprofit group shows a drug company paid Minnesota doctors more than $750,000 in 2008." In fact, "Forest Laboratories Inc. paid 62 Minnesota doctors at least $1,000 each in speakers' fees, with 28 physicians receiving payments of more than $10,000," the Minneapolis Star Tribune (9/3, Moore) reported." The Star Tribune pointed out that "Minnesota was the first among a handful of states requiring drug companies to disclose payments to doctors, and the annual disclosure reports have repeatedly revealed potential conflicts of interest in the way physicians prescribe drugs or conduct clinical research, while adding fuel to a national debate about greater disclosure of the financial ties between industry and" physicians. Nearly one-third "of Forest's payments went to psychiatrists and neurologists, frequent prescribers of antidepressants."

Also in the News

Florida to use portion of Pfizer settlement funds to reward those reporting Medicaid fraud.

The Miami Herald (9/4, Shah) reports, "Florida will use part of its $58 million share of a federal settlement from pharmaceutical giant Pfizer as reward money for tipsters who report Medicaid fraud." The state will use "about $1 million" of the $58 million it received in the settlement to "reward informants whose tips lead to fines, civil or criminal charges or forfeitures of property." Some of the remaining funds "will reimburse the federal Medicaid program for Florida and the state Medicaid program, and nearly $10 million will go into the state's general fund."

Leading News in Pharmacy

Pfizer agrees to $2.3 billion drug-marketing settlement.

The CBS Evening News (9/2, story 5, 0:15, Rodriguez) reported that on Wednesday the government "hit Pfizer, the world's largest drugmaker, with a record $2.3 billion in fines for violating federal drug marketing rules. Among other things, Pfizer was accused of promoting the pain medication Bextra [valdecoxib] for unapproved uses."

NBC Nightly News (9/2, story 6, 0:30, Williams) added that the penalties come from "admitting that the painkiller Bextra and 12 other drugs were promoted for what's known as off-label use, which the FDA says put public health at risk in the process."

ABC World News (9/2, story 2, 2:25, Gibson) reported that "Bextra became a blockbuster, bringing in $1.2 billion a year, as sales reps assured doctors it could be used not just for arthritis, but for any acute pain. The main whistleblower, a former company sales rep, said in a statement, 'at Pfizer, I was expected to increase profits at all costs, even when sales meant endangering lives. I couldn't do that.'" Meanwhile, "in exchange for hearing company sales pitches, doctors were paid up to $1,500 to attend meetings, and were treated to conferences at lush resorts, given air fare, hotels, meals, even massages."

The Washington Post (9/3, Johnson) reports, "Officials at the departments of Justice and Health and Human Services called the agreement with Pfizer and one of its subsidiaries a cautionary example of their strategy to team up with states to police errant healthcare businesses."

"The Justice Department described Wednesday's settlement as the largest in its history," according to the Los Angeles Times(9/3, Meyer). "The settlement reflects an emphasis by the Obama administration on holding US healthcare corporations accountable for their activities, especially in trying to market drugs to patients and doctors for uses that have not been approved, Justice Department officials and legal experts said."

The New York Times (9/3, Harris) adds, "Although the investigation began and largely ended during the Bush administration, top Obama administration officials held a news conference on Wednesday to celebrate the settlement, thank each other for resolving it and promise more crackdowns on health fraud."

Pfizer subsidiary Pharmacia & Upjohn "must pay a $105 million criminal fine" under the agreement, USA Today (9/3, Rubin) reports. "Pfizer "will pay a criminal fine of $1.195 billion" and "has agreed to pay $1 billion in civil damages and penalties to compensate federal healthcare programs for false claims submitted as a result of its marketing Bextra and the other [three] drugs for off-label use or at unapproved dosages." The three other drugs include "Geodon [ziprasidone], an antipsychotic; Zyvox [linezolid], an antibiotic; and Lyrica [pregabalin], an anti-epileptic drug."

The Wall Street Journal (9/3, B2, Rockoff, Kendall, subscription required) noted that the settlement is the third since 2002 in which Pfizer has promised to change its marketing practices. The AP (9/3, Barrett), the Washington Times (9/3, Conery), the Philadelphia Inquirer (9/2, Hill), the Dow Jones Newswire (9/3, Kendall), Reuters (9/3, Berkrot) and Bloomberg News (9/3, O'Reilly, Capaccio) also cover the story.

Regulatory

Jurors consider Merck's Fosamax case.

On the front page of its Business Day section , the New York Times (9/3, B1, Singer) reports, "Drug executives, product liability lawyers and Wall Street analysts are closely watching a jury trial in New York over medical problems associated with Fosamax, a drug" used "to offset the bone loss associated with menopause." The case "is the first of about 900 state and federal cases pending against Merck in which plaintiffs claim that taking Fosamax caused them to develop...osteonecrosis of the jaw." In the current case, the plaintiff, Shirley Boles, "alleges that taking Fosamax from 1997 to 2006 caused her jawbone tissue to die." Merck is currently "trying to complete a $41 billion merger with Schering-Plough," and "industry analysts are closely watching this first trial to gauge Merck's potential financial liability."

The Wall Street Journal (9/3, Bray, subscription required) reports that an attorney for Merck claims Boles' osteonecrosis occurred three years after she stopped taking the drug. Boles, therefore, cannot blame Fosamax for having caused the condition, the attorney contended. Merck is accused of misrepresenting "the drug's safety and" failing "to warn doctors and patients that it might hamper blood flow to the jaw," Bloomberg News (9/3, Weidlich, Fisk) reports. Plaintiffs also contend that Merck failed "to include an adequate warning about Fosamax's risks when the label was changed." Reuters (9/3, McCool) also covers the story.

FDA panel recommends approval for pralatrexate.

The AP (9/3) reports, "A spokeswoman for the Food and Drug Administration said the agency's panel of oncology experts voted 10-4 that [Allos Therapeutics'] drug pralatrexate [Folotyn] would likely benefit patients with T-Cell lymphoma." Allos "has asked the FDA to approve its drug for patients whose cancer reoccurs or has not responded to other drugs," and there are "currently no FDA approved treatments for the disease." The company's "studies of the drug showed 27 percent of patients with T-Cell lymphoma responded to treatment, with more than half responding for about three months." The FDA is expected to decide on the drug by Sept. 24.

Reuters (9/3, Heavey) adds that the FDA, which is reviewing the drug under an expedited process, also cautioned the panel that while the drug seems to have some active effect on T-Cell lymphoma, that effect alone may not be enough to merit approval.

Knopp receives FDA fast track designation for ALS drug.

The Pittsburgh Business Times (9/2) reported, "Knopp Neurosciences Inc. has received fast track designation from the Food & Drug Administration for development of a drug to treat amyotrophic lateral sclerosis, better known as Lou Gehrig's disease." The company "has completed the randomized, placebo-controlled part of its phase two studies of the drug in 102 ALS patients and anticipates starting third-phase studies in the United States and Europe next year." Those participating in the second phase of the study "were offered enrollment in an ongoing, 48-week safety trial, where all participants are receiving the highest dose tested of the Knopp drug, which is known as KNS-760704."

FDA extends review of Endo's Nebido by three months.

The AP (9/3) reports, "The Food and Drug Administration has extended a review of a testosterone drug candidate by three months, the product's maker, Endo Pharmaceuticals Holdings Inc., said Wednesday." The agency "extended its review period to Dec. 2," because it "needs more time to review the application and complete a risk evaluation and mitigation strategy." The drug, Nebido, "a long-acting testosterone undecanoate injection," is "intended to treat hypogonadism."

The agency "has not requested additional data" from Endo, the Philadelphia Business Journal (9/2, George) reported. Nebido is currently "approved in 86 countries worldwide." The drug "was discovered and developed by Bayer Schering Pharma," which "licensed the US rights to the product to Indevus Pharmaceuticals." Endo acquired Indevus "earlier this year." Reuters (9/3, Raj) also covers the story.

Health Coverage and Access

Obama to address joint session of Congress on healthcare reform.

The White House announced Wednesday that the President will deliver a speech to a joint session of Congress next Wednesday night on the issue of healthcare reform. The AP (9/2, Babington) reports that the speech opens "an urgent autumn push to gain control of the debate that has been slipping from his grasp under withering Republican-led attacks." The Administration's "scheduling of the speech next Wednesday night, just a day after lawmakers return from their August recess, underscores the determination of the White House to confront critics of Obama's overhaul proposals and to buck up supporters who have been thrown on the defensive." The timing "also suggests that top Democrats have all but given up hope for a bipartisan breakthrough." The Christian Science Monitor (9/3, Feldmann) reports that "at this point, talk of a bipartisan plan has evaporated. So, analysts say, what he needs to do is unite his own party, in both houses of Congress, and proceed from there."

The New York Times (9/3, A1, Pear, Calmes) reports on its front page that Administration officials said the President "would be more specific than he has been to date about what he wants included in the plan. Doing so amounts to an acknowledgment that the president's prior tactic of laying out broad principles and leaving Congress to fill in the details was no longer working and that Mr. Obama needed to become more personally involved in shaping the outcome." However, "the officials said Mr. Obama was unlikely to unveil a detailed legislative plan of his own," and "insisted" the President had not given up on a public option.

Health Business

Dainippon to buy Sepracor for $2.6 billion.

Bloomberg News (9/3, Matsuyama, Randall) reports, "Dainippon Sumitomo Pharma Co. will buy Sepracor Inc. for $2.6 billion, gaining a US sales force and experimental treatments in the world's biggest drug market." Sepracor "will become a wholly owned unit of Dainippon after the all-cash transaction is completed," according to statement from the companies. Bloomberg adds, "Sepracor has a sales force of 1,200 in the US and is researching drugs including treatments for asthma, allergic rhinitis and insomnia."

The Dow Jones Newswire (9/3, Shimamura) also notes that if the purchase goes through, "Dainippon would be able to open a sales channel in the US for its new schizophrenia drug [Lurasidone] currently in phase-3 clinical studies."

Abbott to develop diagnostic test for Pfizer drug.

The Chicago Tribune (9/3, Japsen) reports, "To tap the growth potential of personalized medicine, the diagnostic business of North Chicago-based Abbott Laboratories will work with Pfizer Inc. to develop a test to determine which patients will benefit from an experimental lung cancer drug being developed by" Pfizer. Abbott's "companion diagnostic test" will help to "'determine a patient's genetic status and will be used in patient selection for future clinical trials' of Pfizer's PF-02341066, a cancer therapy targeting non-small-cell lung cancer." Abbott did not "disclose potential sales for such a companion test."

Research

Study indicates experimental drug may be promising against basal cell carcinoma.

The Wall Street Journal (9/3, Winslow, subscription required) reports that, according to a study published online Sept. 2 in the New England Journal of Medicine, Genentech's experimental drug GDC-0449 appeared to shrink tumors in 18 of 33 patients in the advanced stages of basal cell carcinoma. The drug also temporarily and dramatically helped a 26-year-old man suffering from medulloblastoma, a brain cancer.

HealthDay (9/2, Gardner) pointed out that GDC-0449 "switches off the so-called 'Hedgehog' pathway." HealthDay noted that "the Hedgehog pathway has been implicated in other cancers, notably colon cancer and ovarian cancer, albeit in a different way." Therefore, investigators "are going forward to look at the potential of...GDC-0449 to treat these types of cancers as a one-drug regimen, and in combination with other drugs for other solid tumor malignancies," explained study author Charles M. Rudin, MD, PhD, of Johns Hopkins University. In an accompanying editorial, Andrzej Dlugosz, MD, professor, department of dermatology, University of Michigan Medical School, "noted that finding a compound that might control the Hedgehog pathway could have far-reaching implications."

WebMD (9/2, DeNoon), MedPage Today (9/2, Bankhead), Medscape (9/2, Chustecka), AFP (9/3), Reuters (9/3, Steenhuysen), and the Arizona Republic (9/3, Alltucker) also cover the story.

Research suggests perioperative statin therapy may be linked to improved cardiac outcomes in vascular surgery.

The AP (9/3) reports that individuals "getting an artery unclogged or repaired were much less likely to die or have a heart attack afterward if they took" statins "before and after their operations," according to a study published in the New England Journal of Medicine. Investigators "enrolled nearly 500 patients who were not on statins and were going to have operations on their aorta or leg or neck arteries. For about a month before and a month after their surgery, half the patients took a statin; the" remaining patients were given a placebo. The researchers found that "within a month of the operation, 12 patients in the statin group, about five percent, had died or had heart attacks, compared to 25 patients, or 10 percent, of those who took a dummy pill."

MedPage Today (9/2, Emery) reported that the participants "who took the statin drug also saw a significant drop in total cholesterol, low-density lipoprotein (LDL) cholesterol, and two biomarkers for inflammation, interleukin-6 and C-reactive protein." HealthDay (9/2, Edelson) also covered the story.

Low doses of investigational, delayed-release version of prednisone may benefit RA patients, trial indicates.

MedPage Today (9/2, Gever) reported, "Low doses of an investigational, delayed-release version of prednisone relieved rheumatoid arthritis symptoms in a pivotal phase III trial" that included 350 patients, "paving the way for a US marketing application," Swiss-based Nitec Pharma announced. Investigators found that nearly "49 percent of the Lodotra group achieved ACR 20 responses (20 percent reduction in symptoms according to American College of Rheumatology criteria), compared with 29 percent of those taking placebo." It also "led to a mean 44 percent reduction in morning stiffness, compared with 21 percent in the placebo group. Both differences were highly significant."

Prazosin may reduce trauma nightmares, study suggests.

MedPage Today (9/2, Neale) reported, "Prazosin, a drug originally developed to lower blood pressure but used to treat veterans with post-traumatic stress disorder for years, appeared to reduce debilitating trauma nightmares in soldiers deployed to Iraq in a small, open-label study." For 13 soldiers "treated at a combat stress unit in northern Iraq, there was a significant reduction in mean scores for trauma nightmares and disturbed sleep." MedPage added, "Mean trauma nightmare score on the Clinician Administered PTSD Scale decreased from 7.0 to 2.9."

Also in the News

Union group asks FTC to investigate CVS-Caremark merger.

Bloomberg News (9/3, Wolf) reports that officials from Change to Win, a six million-member union federation, "said it asked the Federal Trade Commission at a meeting today to investigate whether the 2007 merger that created CVS Caremark Corp. has raised prescription drug prices." The union "alleges CVS overcharges consumers, sells private customer data and favors higher-priced drugs in order to collect manufacturer rebates, assertions the company says aren't true." The union also "joins five US senators who have requested a similar probe."

Officials: Pfizer to pay record $2.3B penalty

People familiar with a record settlement to be announced Wednesday say Pfizer Inc., the world's largest drugmaker, will pay a $2.3 billion civil penalty over unlawful prescription drug promotions.

Latest pharmacy news

Antiplatelet drugs, PPIs can be simultaneously prescribed to heart patients, investigators say.

According to Bloomberg News (9/1, Cortez), approximately "two million people worldwide undergo procedures to clear heart arteries each year, then take aspirin plus Plavix [clopidogrel] or Effient [prasugrel] from Eli Lilly & Co. and Daiichi Sankyo Co. to prevent re-clogging." What's more, these patients are "routinely prescribed pills" like Nexium [esomerprazole magnesium] or Prilosec [omeprazole], which are proton-pumps inhibitors (PPIs), "to reduce...stomach acid at the same time, since the other medications can cause gastrointestinal trouble." There have been "concerns that mixing the medications may reduce the effectiveness of" the "blood thinner."

Dow Jones Newswires (9/1, Favole) notes that "earlier this year, the FDA asked Plavix marketers Bristol-Myers and Sanofi to update the drug's label to warn of risks with the drug when used in combinations with PPIs." But new research by Brigham and Women's Hospital appears to contradict earlier studies.

For the study appearing online in The Lancet, WebMD (8/31, Boyles) reported, investigators analyzed the results of two trials -- TRITON-TIMI 38 and PRINCIPLE-TIMI 44 -- with the "larger of the two" including "about 13,600 patients who had a previous heart attack or unstable angina treated with one of the two drugs." One-third of the participants "were also taking a PPI, but PPI use was not found to be associated with an increased risk of a second heart attack, stroke, or cardiovascular death with either of the two anti-clotting drugs."

But "evidence of the pharmacodynamic effect of the PPI-thienopyridine interaction was clear in data from the PRINCIPLE trial,"MedPage Today (8/31, Peck) pointed out. Ralph G. Brindis, MD, MPH, President-elect of the American College of Cardiology, said that "even though there is evidence in the test tube that inhibition of platelet aggregation is diminished with PPI therapy, there is no clinical effect." The new findings should not "be construed as a signal to return to routine prophylaxis with PPI," he added. "But for high risk patients who need these drugs, I think we can be a little more confident using PPIs." Reuters (9/1, Hirschler) also covers the story.

Drug Approvals

FDA approves Valcyte to prevent cytomegalovirus in young kidney, heart transplant patients.

The AP (9/1) reports, "Roche said Monday the Food and Drug Administration approved Valcyte [valganciclovir hydrochloride] to prevent the common cytomegalovirus in children who have received kidney or heart transplants." Valcyte "is already approved to treat Cytomegalovirus Retina, an infection of the eye, in patients with AIDS," and "to prevent cytomegalovirus in kidney, heart and kidney-pancreas transplant patients at high risk."

HealthDay (8/31, Roberts) added that the FDA approved the drug for "children 4 months to 16 years who are undergoing kidney or heart transplant, Swiss drug maker Roche said Monday." Roche also said that as "part of the approval, the FDA sanctioned a new oral liquid form of the drug to allow for easier use in children."

FDA grants doxorubicin orphan drug status.

The AP (8/31) reported, "Delcath Systems Inc. said Monday the Food and Drug Administration gave its developing liver cancer treatment doxorubicin orphan drug status." The status "is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market," and allows "seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits." The AP added, "Delcath focuses on using drug delivery technology that gives ultra-high doses of anticancer drugs to the liver."

Medication Use

FDA approves six new marketable volumes, concentrations of heparin.

The AP (9/1) reports, "Drug delivery system and device maker Hospira Inc. said Monday it received Food and Drug Administration approval to market the blood thinner heparin in six new volumes and concentrations." The doses "range from one milliliter to 30 milliliters in size," according to Hospira, and the "concentrations range from 1,000 units per milliliter to 10,000 units per milliliter." The AP adds, "The approval covers three single-dose vials and three multiple-dose vials."

Quality and Safety

Flu shot focus may be overshadowing necessity of meningococcal meningitis vaccination, experts say.

The AP (9/1) reports that although it can often initially seem "like a stomach bug or the flu," bacterial meningitis "can go on to kill terrifyingly fast." And, the "prime targets are tweens, teens and college freshmen." But there are concerns that the onslaught of flu shot headlines may be overshadowing the need to seek "vaccination against meningococcal meningitis." In the "two years since the government recommended that every adolescent be vaccinated, close to 40 percent of tweens and teens are." But while there "are multiple types of meningitis," nearly "15 percent of the people who catch this fast-moving germ die -- and one in five of the survivors --suffer permanent disabilities including brain damage, deafness or amputated limbs." So, many universities "now require freshmen to be vaccinated, whether they're dorm-dwellers or not." What's more, "a growing number of states are passing legislation making a meningococcal shot a requirement to enter certain grades."

Pharmacy medication errors may be ruled criminal

Every pharmacist makes mistakes, and all too often they are medication errors. Sometimes the system does not catch a medication error and it reaches a patient. Sometimes, thankfully not often, an error injures a patient.
In such an instance, we can be held liable in a civil suit for money damages as compensation for the injury. We carry malpractice insurance because we know that no matter how good we are, we will never eliminate the possibility of a negligent act that may result in human error and injury to a patient.
What if, however, our medication error resulted in a criminal charge? In May, an Ohio pharmacist pleaded "No contest" (essentially equivalent to a guilty plea without admission of guilt) to a charge of involuntary manslaughter. He faces up to five years in prison and a fine of up to $10,000.
We commonly think that a person charged with a crime is a "bad person." The pharmacist in the Ohio case was not a bad person, but a mistake occurred under his supervision that resulted in the death of a two-year-old girl.
There seems little question that negligence was involved. According to newspaper accounts and Board of Pharmacy minutes, a hospital pharmacy technician mistakenly mixed chemotherapy solution with 23.4 percent instead of 0.9 percent sodium chloride. The parents' civil suit charging negligence against the hospital was settled out of court.
Negligence charges are common in civil cases involving professional malpractice. In civil cases, negligence means deviation from professional standards of practice or failure to exercise due care. In criminal cases, negligence means something more. An earlier Ohio court explained:
A person is [criminally] negligent when, because of a substantial slip from the standard of care [the person] fails to take steps to evade a risk that his conduct may cause a certain result. ... It defines a higher degree of negligence than ordinary negligence. For one to be [criminally] negligent ... he must be guilty of a substantial departure from due care, whereas ordinary negligence merely requires a failure to exercise due care.
It does not happen often that a pharmacist is charged with a crime for a medication error. Whether the pharmacist in this case would have been found guilty had the case continued through a trial, we cannot know.
How can a pharmacist "take steps to evade a risk that his conduct may cause a certain result?" Every time we fill a prescription or drug order, there is a chance that we might make a mistake. When we dispense or compound dangerous drugs, i.e., ones that are designated Rx only, any selection of wrong drug or wrong strength could be a "substantial slip" if the only thing we judge by is the result. The only way to actually "evade a risk" of making a mistake that will result in a predictable (certain) outcome is to refuse to fill the prescription or drug order.
Mike Cohen, president of the Institute for Safe Medical Practices, said about this case, "Focusing on the individual is unlikely to have a positive effect in the long run. I have not read anywhere that he purposefully tried to hurt the patient." I agree; nothing I have read about this case indicates that the pharmacist's conduct rose to the level of a criminal violation. A criminal conviction here serves no purpose. It may also have a dangerous, unintended consequence and may result in injury to a future patient.
The Institute of Medicine (IOM) report "To Err Is Human" found that medical errors are among the leading causes of death in the United States; it estimated that each year 40,000 to 98,000 patients die in hospitals from preventable adverse events — medical errors. The IOM, as part of its report, cited studies estimating that there are 7,000 deaths each year just from medication errors. How many of the professionals involved in these cases should be put in jail?
Prosecutors and grand juries, the ones who make such decisions, are as much subject to pressure to "do something" as the rest of us. They need to think hard about this type of case in the future and resist easy, "feel good" decisions. I was taught in law school that a person should be able to conform his or her actions to avoid being charged with a crime. In this case, to conform your actions, you'd have to avoid being a fallible human being — or refuse to fill the drug order.
There is a reason we teach that when a medication error occurs, we fix the system and do not punish the person. This is the basis of risk management and avoidance of medication errors. Systems are in place because people make mistakes. If people never made mistakes, we wouldn't need systems. If systems never failed, none of our mistakes would ever reach a patient.
Routinely punishing the person who made the mistake may make it less likely that we will learn of every mistake. If we do not learn of an error, we will not have a chance to fix the system. The result will be that some day, some patient will be injured when we could have modified the system to prevent the error from reaching the patient. In the present case, it is the prosecutors who need to fix their system.
This article is not intended as legal advice; it is intended to promote thought about ways to reduce medication errors. For legal advice, consult your own attorney.

So far, generic drugs have not gone viral in America

When it comes to generic drugs, American consumers have much to learn about their cost, ingredients, and effectiveness, according to a recently released study by Prescription Solutions and UnitedHealth Group.
Generic drugs have saved the health system an estimated $734 billion over the past decade. Still, many Americans are apprehensive about using them. The study found that nearly a third of Americans surveyed don't believe generics have the same active ingredients as brand-name drugs, or are as effective. Two-thirds of those surveyed did not understand that generics are usually less expensive than brand-name drugs.
"Using generics helps make healthcare more affordable without compromising results. Many Americans erroneously believe that the most expensive drug is always the most effective drug," said Jacqueline Kosecoff, CEO of Prescription Solutions, a pharmacy benefit management organization. "By helping change perceptions, we can help people save money and still get the best treatment available."
As other studies have done, this latest one revealed that tough economic times have forced many Americans to change the way they manage their prescriptions. Specifically, 27 percent of those surveyed said that to save money they have delayed filling, not filled, or not taken a prescription drug as directed. "At a time when rising costs are taking an increasing toll on many American families, especially during the economic crisis, [we are] working to ensure that consumers have access to lower-priced generic drugs," Kosecoff said.
The study also showed that 21 percent of respondents had spoken to their physicians or pharmacists about switching to less expensive drugs. Of those who regularly take generics, 64 percent said that their physicians had suggested generics and 43 percent said their pharmacists had done so.
Nearly half, 47 percent, of all survey respondents take generics, with 82 percent of that group saying they do so because of the lower cost. Of those who do not take generics, 58 percent said there is no generic equivalent available for the drug they need. Of those who don't take generics, 58 percent said they would, if their pharmacists offered identical, less expensive substitutes.

Questions to Pharmacists Rise After Michael Jackson's Death Consumers more alert to overdose risks from prescription drugs, survey suggests

News reports about a possible link between pop star Michael Jackson's death and his alleged abuse of prescription drugs may have increased the public's concern about prescription medication overdose risks, suggests a survey of U.S. pharmacists.

Of the more than 200 respondents who work in home, ambulatory and chronic care practices, 28 percent of the pharmacists saidpatients have been asking more questions about the risks of prescription painkillers since Jackson's death on June 25.

The American Society of Health-System Pharmacists (ASHP) survey was conducted on July 1.

"While circumstances surrounding Michael Jackson's cause of death are still speculative, the media attention has opened dialogue about the dangers of prescription drug abuse," ASHP president Lynnae M. Mahaney, said in a news release.

"Medications can make a tremendous difference for people suffering with chronic pain and these patients should seek treatment," she said. "However, these medications are extremely powerful and when used improperly they can cause serious harm, even death."

Pharmacists, especially those trained in pain management, can assist patients by guiding them towards pain therapy that can minimize their risks for abuse and addiction, according to the ASHP.

The group offers the following safety tips for patients:

• Compile a list of your medications so that you can keep track of which medicines you're taking, including the doses and frequency, and make the list available to your pharmacist and other health care providers.
• Fill all of your prescriptions at one pharmacy, or use those with interconnected computer systems so that they can access your records and check for adverse drug interactions between different medications you're taking.
• If you have questions about your medications, ask your pharmacist.

More information

The U.S. Food and Drug Administration offers a guide to the safe use of pain medications.

Rx drugs are losing to generics in the war for consumer dollars

The rate of prescription abandonment increased 34 percent since 2006, according to an analysis by Wolters Kluwer Health (WKH).

The WKH report found that prescription abandonment — whereby a patient submits a retail prescription but doesn't pick it up — increased from 5.15 percent in 2006 to 6.8 percent in 2008. The study found that abandonment rates increase as co-pays do. New prescriptions with co-pays of $100 or more had an abandonment rate of more than 20 percent, while the abandonment rate for scripts with co-pays of $10 or less was 4 percent. "Price sensitivity is clearly a factor as consumers decide to forgo certain prescriptions altogether, including some for chronic conditions," said Mark Spiers, president and CEO of WKH. "This disturbing trend may have serious health implications and seems poised to continue — especially if the economy deteriorates further."

The WKH analysis also found that generics represented 60 percent of all prescriptions filled in the United States in 2008. The percentage was even higher for oral drugs. According to the report, in 2008 prescriptions were filled for 2.4 billion generic drugs versus 1.4 billion brand-name medications. Generics have seen a growth rate of 12 percent since 2004, while brand-name medications dropped 6 percent during the same period.

"We're close to the point, certainly by the end of 2009, where two out of every three prescriptions filled will be generic," Spiers said. "These trends are going to become even more pronounced moving forward, as there are many blockbusters in major therapeutic areas like cholesterol reducers due to come off patent in the coming three years. The volume of available generics will increase, and there are very few new blockbuster drugs in the pipeline to replace them."

Factors such as increased patient education, increased awareness of the availability of generics, and changing attitudes, Spiers said, have all contributed to the growth of generics usage. "Patients are becoming far more comfortable with the concept of using a generic in place of a brand," he said. "This, in part, is due to patient education programs and enthusiasm forged by marketing vehicles such as $4 generic drug programs."

The worsening economy also has played a role in patient decision-making. As insurers set higher co-pays for brands, patients are choosing to save money with generics. "Increased unemployment and high numbers of newly uninsured are encouraging patients to look for ways to cut costs. Choosing a generic over a brand fits right into that mindset," Spiers said.

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Iran Gifts Books to New Zealand Library

Christmas came early at the Palmerston North City Library, multicultural services librarian Parrill Stribling said after getting two boxes of books from the Iranian Embassy.

Iran is keen to play a full part in Palmerston North's next Festival of Cultures in April, Iran's Deputy Ambassador to New Zealand Ali Maamati said during a visit to the City Library on Friday. Maamati had just donated two boxes of books about Iran to the library, doubling its Farsi (Persian) collection. Later he made a tour of the city facility and shared his admiration of New Zealand libraries. They were more than book repositories, but places of learning, friendship and social interaction, he said. In the absence of city librarian Anthony Lewis, he was met by multicultural services librarian Parrill Stribling and library outreach head Jay Robinson. "We are very pleased to have some collaboration with the Palmerston North City Council and the opportunity to present a selection of books about Iran to Palmerston North," Maamati said. "Books are a good way to become familiar with Iran's art and society and also enhance the understanding between cultures." His embassy recently screened Iranian movies in Christchurch and he would be interested in a similar event for Palmerston North, he said. When told of the annual Festival of Cultures in February, he was interested in bringing the movies to the city then. In the discussion that followed, it was suggested there was an opportunity to introduce music and dance at the festival as well. Stribling described the gift of about 35 books as "wonderful". "Some of these books are very hard to get - particularly the books of poetry. I'm very pleased by the whole thing."

Karimi Saves Persepolis in Derby

TEHRAN - Iran's international superstar, Ali Karimi, scored his first goal since his return to Persepolis and he chose a great moment to do it: two minutes from the end of the Tehran derby against rivals Esteghlal.
The 65th derby between Tehran's two popular clubs, Persepolis and Esteqlal, resulted in yet another tie at a packed Azadi stadium. Two minutes into the game, Hossein Kazemi, made Esteqlal's first goal attempt by taking his chance from distance, but it went just wide. Following the incident the Reds were the dominant side possessing the ball in Esteqlal's ground. A long-range shot by Karim Baqeri hit the Blues' post in the 6th minute. On the 12th minute, Ebrahim Tore missed Perseoplis' best opportunity in the first half, after receiving the ball from Captain Ali Karimi. Karimi missed an excellent opportunity for Persepolis in the 33rd minute. Receiving a cross pass from Baqeri, he dribbled past Esteqlal defender Hashem Beigzadeh but his shot went over the bar. But right after the break, Arash Borhani put the Blues ahead in the 46th minute, taking advantage of a defensive lapse to put Esteghlal 1-0 ahead. Both teams had chances to add to the scoreline. With Esteqlal leading 1-0, Persepolis were staring defeat in the face. Persepolis increased pressure on Esteqlal firing one after another and missing chances from the 18-yard box. Alireza Nikbakht-Vahedi hit an Esteqlal post, Karimi missed a gilt-edged chance and Borhani should have scored at least one more. With time almost over, Karimi sent the Red fans wild with delight with his equalizer and denied the Blues a famous win. Persepolis are in fourth while Esteghlal are in seventh though the season is still young. Zob Ahan are in second after a 6-3 thrashing of a struggling Saipa side. Sepahan won 1-0 at Rah Ahan while Pas and Malavan drew 0-0. Leaders Bargh won the previous day.

Nekounam Saves Iran in Saudi Arabia

Nekounam Saves Iran in Saudi Arabia
TEHRAN - A late header from Javad Nekounam earned Iran a 1-1 draw in Saudi Arabia on Saturday in the opening night of the final round of qualification for the 2010 World Cup.

Twenty-nine minutes into the game, poor defending by Iran allowed Saudi's Saad al-Harthi in the box, who then found himself one-on-one with Iranian goalkeeper Mahdi Rahmati. Al-Harthi accordingly scored with ease. But Saudi Arabia failed to convert three other opportunities. One was repelled by Iran goalkeeper Rahmati and twice shots flew wide. Following the opener, Iranian players struggled to put even 3-4 successful passes together. Every attack however broke down after a few seconds. In the last minutes of the first half, the game slowed down considerably. Saudi Arabia players seemed happy with the result, and Iranian players waited for the half time break. Whatever Iran's coach Ali Daei said during the break, it worked as the Iranian side was much improved in the second half. Iran finally broke Saudi control when Nekounam scored with nine minutes left with a header past goalkeeper Mansour al-Naqi. King Fahd International Stadium in Riyadh was packed with thousands of Saudis, many of them dressed in green, the color of the national flag. To encourage Saudis to attend the match, the entrance fee was waived by the General Presidency for Youth Welfare, the federation that oversees sports. In a reflection of that Saudi fans enjoy off-court theatrics better than on-court heroics, they booed when the Iranian national anthem was played. In Group B, the Saudis and Iranians occupy second and third place respectively. In another match in Group B on Saturday, the United Arab Emirates took on North Korea in the 2010 World Cup Asian qualifiers at the Mohamed Bin Zayid stadium in Abu Dhabi. In the 11th minute, UAE captain Abdulraheem Jumaa picked up a poor clearance from the North Korean defense and ran into the penalty area with just the rival goalkeeper Ri Myong Guk to beat. But under pressure from the keeper Jumaa pulled the shot wide of the post. The UAE wasted numerous chances in the first half and they paid for it when the visitors took a shock lead through an own goal in the 72nd minute. Choe Kum Chol was put clean through with a fine pass into the area and the striker's shot deflected off defender Basheer Saeed, who was inside the six-yard box, and found the back of the net. North Korea doubled the lead in the 80th minute. Substitute striker An Chol Hyok took his time and showed calm nerves as he fired in a low shot from outside the area to beat goalkeeper Obaid Altawla at his near post. North Korea hung onto the one-goal margin and their two-one win to kick-start their World Cup qualifying campaign in style.

Daei Leaves out Karimi for World Cup Qualifier

TEHRAN - Iran's midfield superstar Ali Karimi has been left out of the squad for next month's World Cup qualification game against Saudi Arabia. Karimi has not played since May after he had termed the current squad the weakest in his 10-year presence in the national team. Iranian head coach Ali Daei, who is said not to have a good relation with the former Bayern Munich midfielder, had at that time given an alleged injury as reason for Karimi's omission. But football insiders said that his exclusion was due to the critical remarks. Daei has again called up German Bundesliga players Mehdi Mahdavikia (Frankfurt) and Vahid Hashemian (Bochum) for the September 6 match, the first qualification game in Asia group 2 where Iran will also meet the United Arab Emirates and the two Koreas.

Kiarash Asharioon - Ba'ad Az Marget

سلام دوستان عزیز برای حمایت از فردوسی روی تبلیغات کلیک کنید متشکریم هم میهن

سلام دوستان عزیز برای حمایت از فردوسی روی تبلیغات کلیک کنید متشکریم

Iran to Play Jordan in West Asian Final

TEHRAN - Iran and Jordan will meet in Friday's final of the West Asian Football Federation (WAFF) Championship after successfully negotiating their semi-final matches. Iran defeated Syria 2-0 in the first match. Kianosh Rahmati opened the scoring after six minutes. Ghloamreza Rezaee scored a second eight minutes after the break as Iran seek a fourth regional title after triumphs in 2000, 2004 and 2007. The Iranian national team are preparing for the final round of qualification for the 2010 World Cup which kicks off next month. Iran will face UAE, Saudi Arabia and North and South Korea. Jordan downed Qatar 3-0 thanks to goals from Hassouna Al Sheikh just before the break and second-half goals from Amer Deeb and Odai Al Saify

Iran wins Oman beach volleyball title

The Iranian beach volleyball team has clinched the championship in the international three-day Beach Volley Tournament held in Oman. Iran's team A defeated the Iranian team B 2-0 in the final game of the event on Wednesday, Mehr news agency reported. Iran A won the $1500 prize and Iran B got the $1300 prize. Oman's team B stood in the third place after its win against Libya and took home a sum of $1000. Libya, Thailand, the Philippines, two teams from Iran and three teams from Oman took part in the event August 10-13.

Olympics - day six photos

Gymnast Yang Wei adds another gold to the Chinese collection, winning the men's all-around competition

Italy's Chiara Cainero wins the women's skeet after a dramatic shoot-off with Kim Rhode of the USA and German Christine Brinker

Simmone Morrow of Australia makes contact with a pitch from Li Qi of China at the Fengtai Softball Field

Ekaterina Dyachenko (l) of Russia strikes against Olena Khomrova of Ukraine in the women's team sabre event

Spain (in red) top group B in the basketball qualifiers after a convincing 72-59 victory over Germany

In a match-up between two undefeated teams in the women's hockey it is China who crack, losing 1-0 to the Netherlands

France's Alain Bernard edges out Australia's world record holder Eamonn Sullivan to win the men's 100m freestyle by 0.11 seconds

Japanese breaststroke king Kosuke Kitajima wins the 200m gold, completing the 100m and 200m double for the second Games

China stun Australia's Jessicah Schipper in the 200m butterfly, with Liu Zige lowering her world record and Jiao Liuyang finishing second

Norway's Nila Ann Hakedal dives to make a return in the beach volleyball competition but cannot prevent a 2-0 defeat by the US

Iranian Researchers Produced Stem Cells Making Blood Vessel

The researchers of Tarbiyat-e-Modarress University achieved to separate the stem cells of bone marrow and changing them into the cells making blood vessels, according to the Jam-e-Jam report.
The researcher of the project Dr. Maryam Jazayeri said this system can accelerate treatment in some diseases that afflicted with the damages of blood network.

New Generation of Internet in Iran

The Chairman of the Researching Center for Stem Cells Sciences Dr. Mohammad Javad Larijani said Iran will manufacture Iran National Accelerator within the next 10-15 years, establish Iran National Observatory within the next 5-10 years and join World Grade Network in near future, according to ISNA.
At the side event of the inauguration ceremony of Nano-Tecnology Computer Center at Nano-Tecnology Science Researching Center, Dr. Mohammad Javad Larijani reminded Grade is a part of calculating activities that meets the needs of the scientists from the view point of calculation and processes a huge volume of data.
Translator: Mandana Davar-Kia

US Applies New Sanctions on Iran

The US has clamped unilateral sanctions on five more Iranian entities over their alleged links to and support for Iran's nuclear program, according to Press TV.
The US Treasury Department accused the Iranian entities of providing materials to Iran's nuclear program and banned the American companies from carrying business with those institutions. The new sanctions would also freeze any assets that the Iranian companies might have in the United States. The five entities have been identified as the Nuclear Research Center for Agriculture and Medicine at Karaj, the Isfahan Nuclear Fuel Research and Production Center, Safety Equipment Procurement Co. and Jaza Industrial Co. and Jabbar Ibn Hayyan. The organizations are active in nuclear research, educational programs, laboratory services for nuclear fuel production and establishment of industrial units related to peaceful nuclear energy. "These five nuclear and missile entities have been used by Iran to hide its illicit conduct and further its dangerous nuclear ambitions," said Stuart Levey, the Treasury Department's undersecretary for Terrorism and Financial Intelligence. The West has so far imposed three rounds of sanctions against Iran, threatening the country with the fourth round should it refuse to halt its enrichment. The European Union ratcheted up trade restrictions on Iran Friday, introducing restrictions on public loans and tougher cargo inspections. Also in late June, the European Union agreed to ban Iran's largest bank (Bank Melli) from operating in Europe for allegedly 'providing services to the country's nuclear program'. The EU announced it would exercise vigilance in dealing with all Iranian banks, in particular Bank Saderat. The United States and its European allies accuse Iran of pursuing nuclear weapons program, but Iran rejects the allegations, saying all its enrichment activities are solely aimed at producing fuel for nuclear power production. The country is currently facing electricity shortage.

3rd Water Optimization Festival in Iran

Iran's 3rd Water Optimization Festival is going to be held in the Chitgar Park of the Tehran capital of Iran on Mordad 23, 1387 (August 13, 2008 ) with the cooperation of Chitgar Cultural House and Water & Sewage Bureau", according to Fars News Agency.
The Chairman of the Environment House of the Cultural-Artistic Organization of Tehran Municipality said the festival includes programs including "Children and Water", jugglery, competition, lecturing, and music, aiming at the issue of lack of water and the necessity of being economical in consuming water.
Translator: Mandana Davar-Kia

Iranian Climbers Ascend Mount Ararat

A five-member team of mountaineers from Maragheh, East Azarbaijan, had ascended Mount Ararat in Turkey, the Secretariat of Mountain Climbing Board of Maragheh Mohammad-Reza Monaseb-Fam said on Wednesday.
Mohammad-Reza Monaseb-Fam said the team includes Javad Salam- Zadeh, Taqi Asqarvand, Farshid Sarbaz, Masoud Yossef-Pour and Jafar Ebadi.
The 5,165-meter Mount Ararat is the highest peak in Turkey. This snow-capped, dormant volcanic cone is located in Igdir province, near the northeast corner of Turkey, 16 km west of the Iranian and 32 km south of the Armenian border.

India Defeats Iran in Archery

Iran's Hojjatollah Vaezi has been defeated by his Indian rival in the elimination round of men's individual archery at the Beijing Olympics, according to Press TV.
Vaezi, the only male Iranian archer at the 2008 Beijing Olympic Games, lost 112-98 to his rival Mangal Singh Champia from India and was omitted from the competition on Wednesday morning.
The Indian archer was second in the men's ranking round while Vaezi was placed 64th.
North Korea's Kwon Un Sil managed to beat Iran's female archer Najmeh Abtin 106-96 on Tuesday.

Iran's Mohammadi Loses to Belarusian Wrestler

TEHRAN - Iran's Greco-Roman wrestler Ali Mohammadi was defeated by his Belarusian rival Mikhail Siamionau at the 2008 Beijing Olympic Games. The Belarusian wrestler won a 3-1 victory over Mohammadi in the 66 kg category on Wednesday morning, press tv reported. The Iranian beat his opponent from South Korea in his first encounter. Some 20 wrestlers have participated in the 66 kg class at the 2008 Beijing Olympic Games. Another Iranian Greco-Roman wrestler Hamid Sourian was also defeated by his Korean rival to stand in the 5th place in the 55 kg class on Tuesday.

Olympics - day five photos

Their handball team also enjoy success with a 28-19 win over Brazil at the National Indoor Stadium

The Wukesong Indoor Stadium plays host to Russia's 71-65 win over near neighbours Belarus in the women's basketball

Hungary's Janos Baranyai knows how Michaela Breeze feels - like the Briton, Baranyai collapses in pain during his weightlifting event

Phelps helps to earn the USA a big lead in the 4x200m freestyle relay as he and the team collect another gold and world record

The records keep on coming in the pool with Australia's Stephanie Rice taking gold in the women's 200m individual medley in 2:08.45

Michael Phelps celebrates his 10th career Olympic gold in the style of the greatest ever Olympian, by inspecting his faulty goggles

Italy's Federica Pellegrini wins gold in the women's 200m freestyle, also registering a world record of 1:54.82 in the process

At the Water Cube, the 100m freestyle record gets broken twice in quick succession with Australia's Eamon Sullivan posting 47.05s

A bad day at the hockey pitch for South Africa's men as the jubilant Aussies rack up 10 unanswered goals

China's Olympic-Sized Clean Air Plan

Anxiety has been running high among Olympic athletes about upcoming exposure to Beijing's poor air quality. After a lifetime of hard training, no one wants to cough their way across the finish line.
The big games are less than three weeks away, and the Los Angeles Times reports that Beijing is further cracking down on pollution by yanking cars off the roads, expanding mass transit and staggering work hours. It will be interesting to see what effects this may have, both in terms of clearing the air in the short term and long-term policies around the world.
Until September 20, owners of 3.3 million private cars in Beijing will only be allowed to drive on alternate days, based on whether the last digit of their license plates is even or odd. Those in violation face a $14 fine. Perhaps this idea will be more effective than it has been in Latin America, given the short duration of the plan, the nature of China's more controlled society and the fact that work hours for many employees are also being staggered.
The smog-choked capital has also added 2,000 buses, improved bus routes, extended the hours of operation for mass transit, opened a new subway and light-rail line and banned the dirtiest freight trucks. Also, many of the buildings for the Olympics are being built with green features.
Some greens are calling the changes too little too late, although it could be said that the city is acting swifter than many American cities with polluted air. But the eyes of the world are now on Beijing, and China's booming expansion means the stakes are high. The city reportedly adds 1,000 new cars a week, and 16 of the world's 20 most-polluted cities are in China, according to the Worldwatch Institute.
Hopefully the changes will both make a difference before the games, and spur long-term solutions. With greater awareness about the devastating effects of air pollution comes greater responsibility. China has an opportunity to test its goals of leadership in the world.
Source: the Daily Green

World Heavyweight Champion Rezazadeh Bids Farewell to Contests

World heavyweight weight lifting champion that had several times broken the world records in his class, bid farewell to contests for good here Wednesday, according to IRNA.
Hossein Rezazadeh who is by far the most famous heavy weigh world champion of weight lifting was also known as "Hercules" at sports circles announced his decision to bid farewell to the games in a letter addressed to the Head of Iran's Weight Lifting Federation, Bahram Afsharzadeh.
The letter is in fact a response to Afsharzadeh's earlier letter to Hercules, in which he had mentioned the experts and sports doctors' suggestion that it is time for Rezazadeh to end heavy activities.
Hossein Rezazadeh who during his 15 years of competing at sports scenes gained 14 gold medals for the Iranian nation at world, Asian and Olympic games, and improved the records of the World Weight Lifting several times, is the only sportsman in the history of Iranian sports that won gold medals at two consecutive Olympic Games, namely the Sydney 2000 and the Athens 2004.
Rezazadeh has in his letter said, "I am quite certain that my young friends can quite efficiently repeat the pride we gained at previous Olympics at Beijing 2008 Games, which is why I accept the doctors' advice and bid farewell to this, and future competitions of weight lifting." The popular champion who is leaving the scene of competitions at the peak of success has in his letter also begged the pardon of the Iranian nation, hoping that he would not have ot feel ashamed of him due to factors that are beyond his control.
The 1998 Gold Medal of the 1998 Thailand Asian Games and the 1999 Gold Medal of the Greek World Championship, are only two of the precious medals Rezazadeh gained for the Iranian nation.

Iran to Double Hybrid Car Production

Iranian automakers are to double the production of dual-fuel vehicles in order to reduce the country's heavy dependence on gasoline, according to Press TV.
Some 600,000 hybrid cars are to be manufactured by the end of the (Iranian calendar) year ending March 20, 2009, said Senior Industry Ministry Official Mohsen Salehinia. Iranian companies produced over 314,000 hybrids that utilize both gasoline and compressed natural gas (CNG) during the previous Iranian year which ended March 20, 2008. These (600,000 hybrid) vehicles will make up 33 percent of the country's total auto production, Salehinia added. The rise in hybrid car production has been encouraged by the government to reduce gas consumption in the world's fourth-largest oil producer. Iran lacks adequate refining facilities to produce gasoline and allocates huge sums to import gas, which burdens state coffers. The country introduced a gasoline-rationing program in June 2007. Sixty percent of passenger cars produced this year will use natural gas as fuel or will be dual-fuel, and the remaining 40 percent will run on regular gasoline, read a cabinet statement released in June 2008.

After 10 Yrs, Woman Still at Airport

A middle-aged German woman has chosen a Spanish airport as her residence for 10 years and has no intention of changing it, the Guardian reported.

More than 20 million travelers pass through Palma de Mallorca's airport each year and at first glance Bettina could be just another tourist waiting for a flight home. But she never checks in.
Known only as Bettina, 48, or as "the woman with the cat" has become a fixture at the airport where she washes herself and clothing in restrooms and quietly moves from bench to bench.
She came to Spain after a relationship ended and she lost her job. But employment opportunities there were also limited and she moved into the airport where she lives on gifts of food and money from strangers and friends, reported The Guardian Saturday.
Bettina is reportedly popular among airport staff.
"She is intelligent, discreet and does not bother anyone. She says she has made this her home because she has everything she needs here," cleaner Maria Jesus Rueda Garcia, 54, an airport employee, told The Guardian.
"Things didn't work out so she has come to live here. She can get by and is not a beggar because she has income -- I have seen her take money out of the cashpoint (automated teller machine). This could happen to us all."
Her story recalls the Tom Hanks film The Terminal, which was reportedly inspired by the story of man who lived at Charles de Gaulle airport near Paris for 18 years after his documents were stolen.
Bettina, who refuses to disclose her full name, arrived in Mallorca for a new start but she landed odd jobs working as a waitress then helping in a kitchen.
The dream of living in the sun turned sour. "Suddenly there was no work because they only give jobs to Spaniards," she told the local Diario de Mallorca newspaper. "I wanted to work in Mallorca but I got stranded here."
"One friend brings me something to eat twice a week. Sometimes people give me a bit of money as well, but I don't ask anyone for anything," she said.
She has no desire to return to Germany. "No way. Life is better for me here."
Bettina is not the only one to live in a Spanish airport. Generally, such residents are tolerated so long as they do not bother passengers. In Britain, four people are allowed to live at Gatwick.

Korean wrestler defeats Sourian

Iranian Greco-Roman wrestler Hamid Sourian has been defeated by his Korean rival Park Eun-chul at the 2008 Beijing Olympic Games.

The Korean won the bronze medal after defeating Sourian in the 55 kg class on Tuesday. Sourian won the first round 1-1, but was defeated 2-2 by his opponent in the second round. Eun-chul managed to get two points just 10 seconds before the end of the third round and bagged the bronze. The 23-year-old Iranian wrestler had previously defeated Park Eun-chul two times in world competitions. Sourian defeated his rivals from Bulgaria and Palau in his first two encounters but lost to his Russian opponent in the third match. Sourian won both the Junior World Championships and Senior World Championships in 2005. He was also the 2007 and 2008 Asian gold medalist.

Iran's wrestler loses to Belarusian rival

Iran's Greco-Roman wrestler Ali Mohammadi has been defeated by his Belarusian rival Mikhail Siamionau at the 2008 Beijing Olympic Games.

The Belarusian wrestler won a 3-1 victory over Mohammadi in the 66 kg category on Wednesday morning. The Iranian beat his opponent from South Korea in his first encounter. Some 20 wrestlers have participated in the 66 kg class at the 2008 Beijing Olympic Games. Another Iranian Greco-Roman wrestler Hamid Sourian was also defeated by his Korean rival to stand in the 5th place in the 55 kg class on Tuesday.

Belarus judoka knocks out Iran rival

Iranian judo fighter Hossein Qomi has been defeated by his Belarusian rival Andrei Kazusionak at the 2008 Beijing Olympic Games.

The 24-year-old Belarus judoka knocked Qomi out in the -90 kg category on Wednesday morning. The Iranian judo athlete will be able to compete for a bronze medal if Kazusionak advances to the final by defeating Japan's Hiroshi Izumi. Kazusionak snatched the bronze medal at the 2005 World Judo Championships in Egypt. Earlier, Iran's Arash Miresmaeili was defeated by Japan's Masato Uchishiba in the -66 kg category while Masoud Haji Akhoundzadeh who competed in the -60 kg class lost to Korean gold-medalist Choi Min-ho. A total of 32 judo fighters have participated in the games.

Nekounam scores for Osasuna in friendly

TEHRAN, Iran’s iconic Osasuna midfielder Javad Nekounam assisted his team to fight back from a defeat against Stoke City on Friday.
Osasuna twice came from behind as Walter Pandiani and Javad Nekounam canceled out Ryan Shawcross and Rory Delap’s goals at the Britannia Stadium.
Nekunam opened Sorensen’s goal with a powerful header 15 minutes from time in front of 3,000 spectators.
Another Osasuna Iranian midfielder, Masoud Shojaei, played as a reserved player in the friendly match.

Persian Gulf League [IPL]

... to watch the goals and highlights of Persepolis and Esteghlal visit our youtube page with over 134,197 video views only in three months.

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Mahdavikia rules out Frankfurt departure

FRANKFURT, The Iranian international player, Mehdi Mahdavika has firmly denied reports in the German media indicating that he is on verge of leaving Eintracht Frankfurt. "My name being in Eintrachts's selling list is only a reporter's prediction. If I wanted to get involved in such matters, I should have left Bundesliga 7 or 8 years ago. "I have a contact with Frankfurt until 2010 and I do not wish to leave the club before the end of my contract. Although I respect everyone's opinion, I will only do my job. This has only been a speculation by a reporter and I don't intend to get myself involved. "Moreover, if you take a glance at the last 8-9 years, you will notice many other similar predictions in which I have never been interested , nor I will do ", the 31 year old player told Iranian students news agency ISNA today.The Team Melli Captain added: "It is essential for me to play with highest preparation for my team, I have always performed well in the seasons which I did not play from the beginning, including 2001, 2003 and 2005 Bundesliga seasons. After being injured for one week, I am in a very good situation and have played in almost all preseason friendly matches. "The reason I only played in the last four minutes of the German Cup match that we were playing with only 10 players after a player was sent off during the match and the coach preferred to use me in the last few minutes."We have had an excellent preseason preparation and our team is currently in a very good situation. We have also qualified into the second round of the German Cup and are going to play our last friendly match against Real Madrid this evening. I hope we could have a good start in Bundesliga as we had in the last season which is extremely important for us. I believe we could achieve better results in this season ", the former Asian Player of the year said.In view of his recent invitation to the national team for the second round of the World Cup 2010 Qualification, he said: " I have always emphasized that as an Iranian player, I am fully dedicated to serve the national team and will always give my every best for the success of my country's team ".Mahdavikia singed a three-year deal with Frankfurt in June 2007 after playing eight seasons in Hamburg where he was a crowd favorite. The German bi-weekly kickers sport magazine had reported on Monday that Mahdavikia is on Frankfurt's list of so-called "unwanted players."

Human Afazeli signs a new contract for national team’s coaching job

TEHRAN, Human Afazeli signed a new contract with IFF on Sunday for Iran’s national team coaching job. He will remain assistant to Iran’s head coach, Ali Daei. This is not the first time for Afazeli to be in national level. Afazeli was also assistant to Iran’s former head coaches Branko Ivankovic and Miroslav Blazevic from 2001 to 2006. After qualifying to next stage, Iran is set to compete against Saudi Arabia, UAE, South Korea, and North Korea to secure a spot for next world cup in 2010.

Misaghian takes charge of Esteghlal Ahvaz

TEHRAN --Former Abumoslem coach has been appointed as Esteghlal of Ahvaz coach on Monday. Akbar Misaghian will be officially introduced to the players on Tuesday and is to coach the team in the 3rd week of the Iran’s Professional League (IPL).
Misaghian has succeeded former Esteghlal striker Reza Ahadi as the coach of Esteghlal of Ahvaz.
He has signed a one year contract with an undisclosed fee.

Iran crowned futsal champions

TEHRAN --Iranian futsal team claimed a 9-1 win over Hungary in the Tehran’s Four-a-Side Futsal Tournament at the Azadi Gym on Monday.
Reigning Asian champion Iran had already defeated China and Thailand in the tourney.
Thailand battled to a 2-2 draw with China and finished third due to difference goal. China and Hungary finished third and fourth respectively.
Iran is preparing for the 6th edition of the FIFA Futsal World Cup which takes place in Brazil from September 30th to October 18th.

Lithuania Thrash Iran 99-67

TEHRAN (FNA)- Linas Kleiza had 22 points and Sarunas Jasikevicius 20 to lead Lithuania to a 99-67 trouncing of Iran on Tuesday in a preliminary-round Group A match at the Olympic men's basketball tourney.

The Asian champions had a quick start to lead 20-15 in the first quarter, but Lithuania scored 18 straight points to crush Iranians' confidence. Iran never recovered from that blow and saw themselves down by 74-53 at the end of the third quarter. Lithuania put on bench players to finish the victory. Hamed Ehadadi led Iran by 21 points, nine rebounds, four blocks and three steals, but also committed eight turnovers.

IOC Accepts Iranian Swimmer's Reasoning

TEHRAN - The International Olympic Committee has accepted the explanation of an Iranian swimmer who pulled out of an event that included an Israeli competitor.

An Iranian swimmer withdrew from a race at the Beijing Olympics because of an illness and not due to the presence of an Israeli athlete in the same competition, the International Olympic Committee said Monday. Mohammad Alirezaei withdrew from the heats of the men's 100-meter breaststroke on Saturday just before he was due to compete against a field that included Israel's Tom Beeri. The presence of Israel's Tom Beeri in the same heat was originally believed to be the reason for Alirezaei's withdrawal, but the Iranian athlete cited illness as the reason. Iran could have faced sanctions from the IOC if Alirezaei pulled out deliberately because an Israeli was also racing, but IOC spokeswoman Giselle Davies said Monday that no violation had been found. Davies, who is also director of communications for the IOC, said that Alirezaei withdrew because of sickness and submitted his case in writing to his Federation. "The athlete has withdrawn because of sickness," she said. "He confirmed this in writing to the swimming federation. We've also spoken with the (Iranian) national Olympic committee and they have underlined to us that all their athletes compete here in the right spirit against athletes from any nationality. "We take both the athlete and the national Olympic committee at their word on this," she said.

Iran Beat Qatar in WAFF Championship

TEHRAN - Defending champions Iran routed Qatar 6-1 to top the group in the West Asian Football Federation (WAFF) Championship while Jordan got the better of Oman 3-1 to grab the last semi-final spot on Monday.

Milad Meydavoudi opened the scoring for Ali Daei's side in the 10th minute and Ahmad Al-e Ne'me doubled the lead three minutes past half hour. Defender Hadi Aghili scored the third from the spot three minutes into the restart. Meydavoudi completed his brace in the last minute. Ehsan Haj Safi (62) and Jalal Rafkhahi (83) sealed the fate of the West Asians. Meshaal Abdullah scored the consolation goal for an under-strength Qatar in the 52nd minute. Daei, who fielded a second-string side in this six-nation tournament, will now have a bigger pool of players to select from for the 2010 FIFA World Cup Asian qualifiers starting next month. Mohammad Katkout cancelled out Hassan Abdul Fattah's sixth minute opener for Jordan from the spot in the 26th minute but a brace from Raed Al Nawateer in the 71st and 84th minutes helped Jordan set up the semi-final with Qatar. Iran will face Syria in another semi-final on Wednesday. The final will be played on Friday.

Iran's Gold Favorite Soryan Loses

TEHRAN - Iran's Olympic gold medal favorite Hamid Soryan lost in the Greco-Roman 55kg quarter-final to Russia's Nazyr Mankiev on Tuesday.

Soryan has dominated the category over the past three years winning three consecutive world titles in 2006, 2007 and 2008 and two Asian championship gold medals, but lost 3-1 on classification points after he tied 4-4 on technical points with Mankiev. The 23-year-old Iranian wrestler defeated his rivals from Bulgaria and Palau in his first two encounters and must now fight for the bronze medal. In the 60kg category, two-times Olympic champion Armen Nazarian of Bulgaria narrowly fought past Japan's Makoto Sasamoto to make the quarter-finals where he will face Vitaliy Rahimov of Azerbaijan. Georgia's David Bedinadze, one of the strongest in the category, lost to Nazarian in qualifying but could still pick up a bronze medal through the repechage.