Friday, January 13, 2012

Morning HCV News Ticker:Walgreen Overcharging For Generics ?

Norman Rockwell, 1930, At the Breakfast Table

Walgreen Co., the biggest U.S. drugstore chain, and generic drugmaker Par Pharmaceutical Cos. (PRX) swapped prescription-drug tablets for more expensive capsules to boost profits, a union benefits fund claimed in a lawsuit.

“Walgreen’s and Par engaged in at least two widespread schemes to overcharge insurance companies, self-insured employers and union health and welfare funds,” the United Food & Commercial Workers Unions & Employers Midwest Health Benefits Fund said in a complaint filed yesterday in federal court in Chicago.

The drugs involved included generic versions of Zantac and Prozac, according to the complaint. The fund and other third- party payers paid millions of dollars more for the capsules than they would have for the correctly prescribed tablets, said the fund, which is seeking to sue on behalf of all third-party payers in the U.S. from 2001 to 2006.

The companies’ actions violated federal racketeering laws, according to the complaint. The fund is asking for unspecified cash damages.

Vivika Panagiotakakos, a spokeswoman for Deerfield, Illinois-based Walgreen, declined to comment on the filing.

In 2008, Walgreen agreed to pay $35 million to settle claims by the U.S. and 42 states that it was overcharging state Medicaid programs for ranitidine -- a generic form of the antacid Zantac -- and for fluoxetine, a generic form of the antidepressant Prozac.

Whistle-Blower Lawsuit

The Chicago case relies in part on that accord, which ended a 2003 whistle-blower lawsuit as well a lawsuit filed against the drugmaker in 2006.

The media relations department of Woodcliff Lake, New Jersey-based Par didn’t immediately reply to an e-mailed request for comment on the suit after regular business hours.

The case is United Food and Commercial Workers Unions and Employers Midwest Health Benefits Fund v. Walgreen Co. (WAG), 12-cv- 00204, U.S. District Court, Northern District of Illinois (Chicago).

To contact the reporter on this story: Andrew Harris in Chicago at aharris16@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net


Doc In AstraZeneca Bribe Scandal Commits Suicide
A key figure in a scandal in which AstraZeneca was indicted in Serbia over allegations of offering bribes to physicians has committed suicide. Nenad Borojevic, who was the former director of the Serbian Institute of Oncology and Radiology Nenad Borojevic, was found hanging from a tree in a forest in Belgrade, according to media reports..continue reading

Hepatitis C Worldwide

Hep C threat to health services
The large number of people in Ireland with hepatitis C poses serious implications for the national health services in the future, the Health Protection Surveillance Centre (HPSC) has warned.

A recent study has estimated that between 20,000 and 50,000 people in Ireland are now chronically infected with hepatitis C.

HPSC Director Dr Darina O’Flanagan said this would have serious implications for health services in the future as a significant proportion of those with hepatitis C would go on to develop cirrhosis, liver failure and hepatocellular carcinoma. “In this regard, the anticipated publication of the National Hepatitis C Strategy in 2012 is to be welcomed,” the public health specialist commented.

She said once again, very large numbers of cases of hepatitis C were reported in 2010, with over 1,200 cases reported for the first time in that year.
Dr O’Flanagan made her comments in the HPSC Annual Report 2010 published recently.

The number of cases of hepatitis C reported in 2010 was very similar to 2009, with 1,239 notifications (29/100,000 population) compared to 1,241 in 2009). Some 67 per cent of cases (833) were male, and the highest notification rates were in young to middle-aged adults. Seventy-two per cent (896) of cases were aged between 25 and 44 years old.

The geographic distribution of cases was skewed, with the HSE-East reporting 76 per cent of all cases notified in 2010. The highest notification rates were also in the HSE-East (63/100,000 population, 940 cases).

According to the data, available for 59 per cent of cases (728), the most common risk factors reported were injecting drug use (76 per cent or 550), being an asylum seeker/born in an endemic country (9 per cent or 63 cases), sexual exposure (5 per cent, 38) and receipt of blood or blood products (3 per cent, 19). lloyd.mudiwa@imt.ie

Hepatitis E

China approves hepatitis E vaccine

BEIJING, Jan. 11 (Xinhua) -- China has approved a hepatitis E vaccine, claimed to be the world's first, said the Ministry of Science and Technology Wednesday.

The vaccine received the certificate for medicine production in December 2011, according to the State Food and Drug Administration.

A team of researchers from Xiamen University and Xiamen Innovax Biotech Co. Ltd. in southeast China's Fujian province had worked for 14 years to develop the vaccine, and the 863 program, the government-funded high-tech development initiative, began to sponsor the research in 2005, said the ministry statement.

The country will apply the vaccine to high-risk members of the population and work with international organizations to introduce it to other countries, the statement said.

The hepatitis E virus is shed in feces and spread via tainted water and food. According to the World Health Organization, one third of the global population is estimated to be infected by the virus and countries in South and East Asia report about 6.5 million infection cases every year.

In China, incidences of hepatitis E have increased notably and become the most common among all types of hepatitis infecting adults.

According to a research paper from the vaccine's development team published in The Lancet in August 2010, researchers conducted a trial involving 97,356 healthy participants in China. Half of them were given the vaccine and the other half a placebo.

The vaccine was given in three doses -- the second was given a month after the first and the third five months later.

Within a year of the third dose, 15 of the participants who were given placebos had contracted hepatitis E while no one in the vaccine group was infected, according to the report.

HIV

HIV transmission: 1 in 900 sex acts transmits virus

A heterosexual person infected with HIV will transmit the virus to their partner once in every 900 times the couple has unprotected sex, according to a new study conducted in Africa.

However, the exact number of sexual acts that are needed to transmit the virus can vary tremendously depending on the amount of the virus in the infected person's blood, said study researcher James Hughes, of the University of Washington in Seattle.

In fact, the amount of virus in the blood is the single most important factor in determining whether HIV is passed between sexual partners, the study found. For every tenfold increase in the concentration, there is about a threefold increase in the risk of transmission during a single sexual act.

People with very high blood concentrations of the virus (such as those who very recently acquired the infection) may need to have sex only 10 times to transmit the virus, Hughes said. "The average can be a little deceptive," Hughes said.

The new findings reinforce the idea that the best methods for reducing HIV transmission are those that decrease the concentration of the virus in the blood, as can be done with antiretroviral drugs, Hughes said. A study published last year found the drugs could reduce the transmission of HIV between partners by 96 percent.

The new study also confirmed condoms are highly effective in preventing HIV infection, reducing the risk of transmission by 78 percent. Male circumcision reduced the risk of HIV transmission by 47 percent.

HIV transmission

Earlier studies attempted to estimate the rate of HIV transmission, but were typically quite small, and did not measure the concentration of the virus in the blood throughout the entire study period.

The new study included 3,297 couples from sub-Saharan Africa that were "HIV-discordant," meaning one partner had HIV while the other did not. The HIV-infected partners in the study were tested periodically over the two-year study for the amount of HIV in their blood. Infected partners were also interviewed every month and asked how many times they had sex, and whether they used protection.

The uninfected partners were tested periodically to see whether they had acquired HIV. The researchers used genetic testing of the virus to confirm that any new HIV infections had been acquired from the study partner designated at the study's start.

Eighty-sixHIV transmissions occurred during the study period.

Men were about twice as likely to transmit HIV to women as women were to men. This increased risk of transmission could be attributed to higher virus concentrations in the blood of men compared with women, according to the study. In addition, women were more likely to have genital herpes, which increases susceptibility to HIV.

Condoms were reported to be used in 93 percent of sexual acts, but the researchers suspect their use was overreported. Therefore, condoms actually may be even more effective at preventing HIV transmission than the 78 percent reduction that the researchers estimated, Hughes said.

The AIDS epidemic

The study relied on self-reports, which might be wrong. However, errors in reports of the number of sexual acts would be unlikely to affect most of the study results, Hughes said.

The average risk of HIV infection per sexual act estimated in the study is consistent with what has been found by previous research, but there are many situations in which that number may not apply," said Dr. Myron Cohen, a professor of medicine, microbiology, immunology and public health at the University of North Carolina at Chapel Hill, who was not involved in the work.

That's because the participants included in the study are couples that have remained together and discordant over a long period of time. This indicates the couples might have some biological protection against transmission, Cohen said.

"The true estimation might be higher if you were studying different kinds of people," Cohen said.

While most of the findings are likely generalizable to other countries, the number of sexual acts needed to transmit the virus is likely specific to the African population studied, Hughes said. Previous studies in the United States have found a lower transmission rate.

In addition, the findings only apply to heterosexual couples, and not men who have sex with men, a group that is likely to have a much higher transmission rate, Hughes said.

Pass it on: The best way to reduce the risk of HIV transmission is to lower the amount of the virus in the blood.

Cancer


Table 1. American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Prevention

View Full Text Here...

The ACS publishes Nutrition and Physical Activity Guidelines to advise health care professionals, policymakers, and the general public about dietary and other lifestyle practices that reduce cancer risk.13 These Guidelines, updated in 2012 by the ACS Nutrition and Physical Activity Guidelines Advisory Committee, are based on synthesis of the current scientific evidence on diet and physical activity in relation to cancer risk.

ACS RECOMMENDATIONS FOR INDIVIDUAL CHOICES

Achieve and maintain a healthy weight throughout life.

• Be as lean as possible throughout life without being underweight.
• Avoid excess weight gain at all ages. For those who are currently overweight or obese, losing even a small amount of weight has health benefits and is a good place to start.
• Engage in regular physical activity and limit consumption of high-calorie foods and beverages as key strategies for maintaining a healthy weight.
Adopt a physically active lifestyle.
• Adults should engage in at least 150 minutes of moderate intensity or 75 minutes of vigorous intensity activity each week, or an equivalent combination, preferably spread throughout the week.
• Children and adolescents should engage in at least 1 hour of moderate or vigorous intensity activity each day, with vigorous intensity activity occurring at least 3 days each week.
• Limit sedentary behavior such as sitting, lying down, watching television, or other forms of screen-based entertainment.
• Doing some physical activity above usual activities, no matter what one's level of activity, can have many health benefits.
Consume a healthy diet, with an emphasis on plant foods.
• Choose foods and beverages in amounts that help achieve and maintain a healthy weight.
• Limit consumption of processed meat and red meat.
• Eat at least 2.5 cups of vegetables and fruits each day.
• Choose whole grains instead of refined grain products.
If you drink alcoholic beverages, limit consumption.
• Drink no more than 1 drink per day for women or 2 per day for men

View Full Text Here...

Healthy You


Salt Shakedown -- How to avoid hidden sodium at the grocery store

Uploaded by on Jan 11, 2012

Join Johns Hopkins registered dietitian, Arielle Rosenberg, as she walks through the aisles and offers suggestions on how to lower salt intake -- but not compromise flavor.





Sugary soda ups risky fat deposits

By Kerry Grens

NEW YORK | Thu Jan 12, 2012 2:22pm EST

NEW YORK (Reuters Health) - Drinking a liter of regular cola every day increases the amount of fat in the liver and in the muscles and surrounding the organs in the belly, according to a new Danish study.

That kind of fat buildup has been linked in other studies to an increased risk of diabetes and heart disease.

"This study suggests that the adverse effects of sugary beverages go beyond just weight gain or fat gain. It's the gaining of the wrong fat in the wrong places," said Dr. Frank Hu, a professor at the Harvard School of Public Health, who was not involved in this study.

The researchers, led by Dr. Bjrn Richelsen at Aarhus University Hospital in Denmark asked people to drink either a liter of water, milk, diet cola or regular cola each day for six months.

The 47 people who participated in the study were all overweight or obese.

Richelsen said his team chose to study this group because they anticipated overweight or obese people would be more sensitive to dietary changes than people of normal weight.

At the end of the study the regular cola drinkers ended up with 25 percent more fat surrounding their organs, and just about doubled the amount of fat in the liver and muscle.

Such increases "are in most studies associated with an enhanced risk for developing the metabolic syndrome, type 2 diabetes...cardiovascular diseases, and non-alcoholic liver diseases," Richelsen told Reuters Health by email.

Metabolic syndrome is a group of health factors that is linked to an increased risk of diabetes, heart disease and stroke.

The type of fat Richelsen's group studied -- called ectopic fat -- is thought to be more dangerous to people's metabolic health than "subcutaneous" fat, the kind that collects under the skin.

"It is well-established that ectopic fat is 'unhealthy' and induces dysfunction of the organs involved," Richelsen said.

Hu said the results from Richelsen's experiment complement those that have surveyed people about their soda drinking habits.

"This study provides another piece of evidence to support the recommendations for the reduction of sugar-sweetened beverage consumption," Hu told Reuters Health.

DO SODA TAXES WORK?

The American Heart Association recommends drinking no more than about three cans of soda a week, while young men far exceed that, with about two cans a day on average (see Reuters Health report of August 31, 2011).

Some cities and states in the United States have batted around the idea of a tax on sugar-sweetened drinks to curb people's consumption.

Denmark has instituted a tax on sugary items, but Richelsen said it's not clear how it has impacted consumers.

One study at a hospital cafeteria found that raising the price of soda by 35 cents reduced sales by 26 percent (see Reuters Health report of June 18, 2010).

The current study, published in the American Journal of Clinical Nutrition, did not find that the cola drinkers gained more weight than the other groups.

Richelsen said it's possible that the people reduced the amount of calories they ate or drank to compensate for the extra calories in the pop.

The researchers point out in their study that the sugar in soda from Denmark is different from most sodas in the United States.

In Europe, the sweetener is sucrose, as opposed to the high fructose corn syrup used in the U.S.

"It is quite convincing from the scientific literature that it is the fructose part of the sugar molecule...that is the primary culprit in inducing fat synthesis in the liver," Richelsen said.

Given that there is extra fructose in high fructose corn syrup, Richelsen said, soda from the U.S. could lead to more pronounced problems with fat gain.

SOURCE: bit.ly/x5kwKU

Red wine-heart research slammed with fraud charges

American Journal of Clinical Nutrition, online December 28, 2011.

NEW YORK | Thu Jan 12, 2012 11:16am EST

NEW YORK (Reuters Health) - A University of Connecticut researcher who studied the link between aging and a substance found in red wine has committed more than 100 acts of data fabrication and falsification, the university said Wednesday, throwing much of his work into doubt.

Dipak K. Das, who directed the university's Cardiovascular Research Center, studied resveratrol, touted by a number of scientists and companies as a way to slow aging or remain healthy as people get older. Among his findings, according to a work promoted by the University of Connecticut in 2007, was that "the pulp of grapes is as heart-healthy as the skin, even though the antioxidant properties differ."

"We have a responsibility to correct the scientific record and inform peer researchers across the country," Philip Austin, the university's interim vice president for health affairs, said in a statement.

The university said an anonymous tip led to an investigation that began in 2008. A 60,000-page report -- the summary of which is available at bit.ly/xkyS4A -- resulted, outlining 145 counts of fabrication and falsification of data. Other members of Das' laboratory may have been involved, and are being investigated, the report continues.

UConn has "declined to accept $890,000 in federal grants awarded to" Das, according to the statement, and has begun dismissal proceedings. The university has alerted 11 journals that published Das' work, and has also worked on the case with the U.S. Office of Research Integrity, which investigates alleged misconduct by federal grant recipients.

The journals include Antioxidants & Redox Signaling, where Das was one of the editors in chief, and the Journal of Agriculture and Food Chemistry.

Although many scientists have been skeptical of various claims made about resveratrol, it has garnered significant commercial interest. GlaxoSmithKline bought Sirtris, a company that worked on the compound in 2008 for $720 million, but later discontinued work on one version of a drug that mimics its activity because of disappointing results.

A Las Vegas resveratrol maker called Longevinex has promoted Das' research, and he appears in a lengthy video touting the nutrient as the next aspirin.

Das also shared a 2002 patent on the use of another compound in grape skins called proanthocyanidin to prevent and treat heart conditions.

Other scientists have taken notice of Das' work, citing 30 of his papers more than 100 times each, according to Thomson Scientific's Web of Knowledge. Last year, he won an award from the International Association of Cardiologists.

Still, one aging researcher said the impact of the fraud on the field will be minimal.

"There are many investigators who are working on resveratrol," said Dr. Nir Barzilai, of Albert Einstein College of Medicine. "That doesn't mean we know the whole truth. But Rome wasn't built on Dr. Das."

Das, who could not be reached for comment, said in a 2010 letter to university officials that the investigation was a "conspiracy" against him. The work was "repeated by many scientists all over the world," he wrote.

"As you know, because of the development of tremendous amount of stress in my work environment in recent months, I became a victim of stroke for which I am undergoing treatment," he wrote in a separate letter.

(With reporting by Adam Marcus)

For You Reading Pleasure

Grand Rounds is a weekly summary of the best health blog posts on the Internet. Each week a different blogger takes turns hosting Grand Rounds, and summarizing the best submissions for the week.

Hosted this week by Thirty Three Charts

Medical Grand Rounds – January 10th, 2012

January 10, 2012

Welcome to this edition of Medical Grand Rounds. I scoured the web and pulled together what I think are some of the more interesting posts and news items of the past couple of weeks. I’ve tried to explore some voices that perhaps haven’t crossed your radar. We’ve got sociologists, medical students, IT gurus, medical futurists and even a couple of doctors. Some of the discussions have related posts that you might find interesting. Posts are not listed in any particular order.

The Weather, Arthritis and Woody Allen’s Orgasmatron

Ronan Kavanagh, Ronan Kavanagh’s Blog

Any post that invokes Woody Allen’s orgasmatron in furthering our understanding of rheumatology has my attention. Galway rheumatologist Ronan Kavanaugh offers some interesting history and touches on the debate surrounding the weather and our joints. I think that the history and debate surrounding this phenomenon could be fashioned as a compelling long-form article or book

Trap Door Days

Claire McCarthy, Thriving

If you don’t think that a doctor can be a patient (or parent) you might consider takin’ a walk in Claire McCarthy’s shoes. Understanding the pain and perspective of a parent who has lost a chronically ill child is something that few understand. And post offers an important look inside the mind of a mother who happens to be a pediatrician living each holiday with the memory of her greatest loss. Claire lives and writes at Thriving, Boston Children’s Hospital’s blog.

I think that it’s this type of narrative that helps the world understand truly the mind of a physician.

Read all submissions here....

Of Interest

32 Million Americans Have Autoantibodies That Target Their Own Tissues
Released: 1/13/2012 7:30 AM EST

Source: National Institute of Environmental Health Sciences (NIEHS)

Newswise — More than 32 million people in the United States have autoantibodies, which are proteins made by the immune system that target the body’s tissues and define a condition known as autoimmunity, a study shows. The first nationally representative sample looking at the prevalence of the most common type of autoantibody, known as antinuclear antibodies (ANA), found that the frequency of ANA is highest among women, older individuals, and African-Americans. The study was conducted by the National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health. Researchers in Gainesville at the University of Florida also participated.

Earlier studies have shown that ANA can actually develop many years before the clinical appearance of autoimmune diseases, such as type 1 diabetes, lupus, and rheumatoid arthritis. ANA are frequently measured biomarkers for detecting autoimmune diseases, but the presence of autoantibodies does not necessarily mean a person will get an autoimmune disease. Other factors, including drugs, cancer, and infections, are also known to cause autoantibodies in some people.

“Previous estimates of ANA prevalence have varied widely and were conducted in small studies not representative of the general population,” said Frederick Miller, M.D., Ph.D., an author of the study and acting clinical director at NIEHS. “Having this large data set that is representative of the general U.S. population and includes nearly 5,000 individuals provides us with an accurate estimate of ANA and may allow new insights into the etiology of autoimmune diseases.” The findings appear online in the Jan. 11 issue of the journal Arthritis and Rheumatism.

Miller, who studies the causes of autoimmune diseases, explains that the body’s immune system makes large numbers of proteins called antibodies to help the body fight off infections. In some cases, however, antibodies are produced that are directed against one's own tissues. These are referred to as autoantibodies.

A multi-disciplinary team of researchers evaluated blood serum samples using a technique called immunofluorescence to detect ANA in 4,754 individuals from the 1994-2004 National Health and Nutrition Examination Survey (NHANES). The overall prevalence of ANA in the population was 13.8 percent, and was found to be modestly higher in African-Americans compared to whites. ANA generally increased with age and were higher in women than in men, with the female to male ratio peaking at 40-49 years of age and then declining in older age groups.

“The peak of autoimmunity in females compared to males during the 40-49 age bracket is suggestive of the effects that the hormones estrogen and progesterone might be playing on the immune system,” said Linda Birnbaum, Ph.D., director of NIEHS and an author on the paper.

The paper also found that the prevalence of ANA was lower in overweight and obese individuals than persons of normal weight. “This finding is interesting and somewhat unexpected,” said Edward Chan, Ph.D., an author on the study and professor of the Department of Oral Biology at the University of Florida.

“It raises the likelihood that fat tissues can secrete proteins that inhibit parts of the immune system and prevent the development of autoantibodies, but we will need to do more research to understand the role that obesity might play in the development of autoimmune diseases,” said Minoru Satoh, M.D., Ph.D., another author on the study and associate professor of rheumatology and clinical immunology at the University of Florida.

The researchers say the paper should serve as a useful baseline for future studies looking at changes in ANA prevalence over time and the factors associated with ANA development. The paper is the first in a series analyzing these data from the NHANES dataset, and exploring possible environmental associations with ANA.

Reference: Satoh M, Chan EKL, Ho LA, Rose KM, Parks CG, Cohn RD, Jusko TA, Walker NJ, Germolec DR, Whitt IZ, Crockett PW, Pauley BA, Chan JYF, Ross SJ, Birnbaum LS, Zeldin DC, Miller, FW. 2012. Arthritis and Rheumatism; doi: 10.1002/art.34380 [online 2012 January 11].

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The NIEHS supports research to understand the effects of the environment on human health and is part of NIH. For more information on environmental health topics, visit www.niehs.nih.gov. Subscribe to one or more of the NIEHS news lists (www.niehs.nih.gov/news/releases/newslist/index.cfm) to stay current on NIEHS news, press releases, grant opportunities, training, events, and publications.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH...Turning Discovery Into Health


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