UPenn Med School Partners With Pfizer For Clinical R&D

(previously published at thebulletin.us)

By: Heather J. Chin, The Bulletin

06/26/2008

Philadelphia - The University of Pennsylvania School of Medicine has entered into a three-year partnership with pharmaceutical research giant, Pfizer Inc., to collaborate in the areas of scientific research, clinical development and clinical care and policy.

Pfizer will pay Penn $15 million over the course of the three years, during which time project proposals will be solicited and reviewed by a committee with members representing both the industry and academia.

Projects chosen will address several therapeutic areas of basic and translational research, initially focusing on the neurosciences and oncology before possibly expanding to other areas of specialization.

According to the National Institutes of Health's Roadmap of Re-engineering the Clinical Research Enterprise, basic research is the phase where scientists study disease at a molecular and cellular level. Translational research is when these basic tools are applied towards patient treatment, allowing doctors to make observations about disease progression that can be used for further clinical research.

Another aim of the partnership is to develop an initiative to improve the management of cardiovascular risk and patient adherence to treatment, with the goal of using those results to create similar programs at other academic centers.

Patients for the pilot program will be those currently served by the University of Pennsylvania's Health System.

In the realm of clinical policy, the partnership will also enable the University and Pfizer to go over how health-care policy is currently applied in patient treatment and care.

"We are excited to work wit Pfizer in a manner that spans the health care continuum, from pre-clinical research through patient care, in a way that can serve as a model for optimal interactions between industry and academia," said Arthur H. Rubenstein, MBBCh, Executive Vice President of the University of Pennsylvania for the Health System, and Dean of the School of Medicine, in a Pfizer press release.

Since 1985, Pfizer and the UPenn's School of Medicine have had an ongoing relationship in the area of clinical studies, with Pfizer sponsoring 130 studies at Penn across 10 therapeutic areas, including oncology, psychiatry and infectious disease.

Heather J. Chin can be reached at hchin@thebulletin.us

©The Evening Bulletin 2008

West Nile Found Outside Lancaster

(previously published here at thebulletin.us)

By: Heather J. Chin, The Bulletin

06/26/2008

Philadelphia - Warm summer weather is the start of many things, including the West Nile season. The second batch of virus-carrying mosquitoes in the Greater Philadelphia area was found yesterday in East Hempfield Township, in Lancaster County. The infected mosquitoes were found in standing water within a series of culverts, said Matt Mercer, interim West Nile virus coordinator for Lancaster Country, to Lancaster Online.

Mosquitoes that had been found at the same spot in previous years were sprayed with insecticide. In 2003, 237 human cases of West Nile virus infections were reported, nine of which proved fatal. Of the total, 37 cases were residents of Lancaster County, two of whom died.

During each of the past two years, nine cases of West Nile virus infections were reported in Philadelphia in humans. Last year, all of those affected recovered, while in 2006, two people died.

This decline in the number of human cases reported in Pennsylvania is good news, and to keep that number down, the Department of Environmental Protection gave Lancaster Country $123,000 this year for virus control efforts.

According to Mr. Mercer, a portion of that money is being used to trap and sample mosquitoes in at least 15 locations each week. Breeding hotspots are injected with a bacteria that prevents larva from maturing and if other areas are found to have a high concentration of adult mosquitoes, they get sprayed as well.

Mr. Mercer says that so far, these methods along with dry weather, "is working out well."

©The Evening Bulletin 2008

Philadelphia Foundation Awards $2.75M To Regional Nonprofits

(first published here at thebulletin.us)

By: Heather Chin, The Bulletin

06/25/2008

Philadelphia - The Philadelphia Foundation announced last Thursday that it has awarded $2.75 million in grants to community noprofits in the Greater Philadelphia area, nearly $1.6 million of which went to organizations in the city of Philadelphia.

A total of 196 grants were given to 161 organizations throughout Bucks, Chester, Delaware, Montgomery and Philadelphia counties. Grant amounts ranged from less than $100 to over $300,000.

Receiving some of the largest grants were Philadelphia nonprofits: the Children's Hospital Foundation receivied $334,000; the Trustees of the University of Pennsylvania were awarded $224,000; the Regional Performing Arts Center received $180,000; the School District of Philadelphia received $67,000 for charitable medical and dental care.

Other beneficiaries this year include the Jamestown Historical Society (nearly $6,000 for windmill preservation and upkeep) and the Settlement Music School (around $3,500 for general operations and scholarships).

The grants were distributed from the Philadelphia Foundation's designated funds, which are established by donors to fund specific charities and which are awarded annually in June. Out of the 775 funds managed by the foundation, 99 of these are designated funds.

The Philadelphia Foundation was established as a public charity community foundation in 1918 with a stated mission of improving the quality of life in Southeastern Pennsylvania through permanent charitable trust funds. Over the last 10 years, the Foundation has awarded $171 million in funds to area organizations.

Heather J. Chin can be reached at heather.jean.chin@gmail.com

©The Evening Bulletin 2008

An Alzheimer's Minibreakthrough

(previously published at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

06/24/2008

The dementia and loss of mental faculties resulting from Alzheimer's disease has long been recognized, but the exact cause has remained elusive, until perhaps now.

New research suggests that one form of beta-amyloid protein - which clumps around an afflicted brain's neurons and forms plaque that inhibits and destroys neurons needed for daily functions and memories - causes symptoms of Alzheimer's.

Previous research had been unable to determine whether the beta-amyloid plaque was a cause or a side effect of Alzheimer's disease.

In the new study, researchers caused Alzheimer's symptoms of impaired memory function in rats by injecting them with a two-molecule soluble form of beta-amyloid protein.

One-molecule and three-molecule forms of both soluble and insoluble proteins did not trigger illness in the rats, which researchers say may explain why some people with beta-amyloid plaque don't exhibit such symptoms.

Dr. Ganesh M. Shankar and Dr. Dennis J. Selkoe of Harvard Medical School published their findings in Sunday's online edition of the journal Nature Medicine. In the report, they noted that when studies were also conducted on mice, the brain cell density was reduced by 47 percent, and affected the synapses, or connections between cells that are necessary for cell communication.

Beta-amyloid extracts were taken from the brains of people who had donated their bodies to medical research.

This is the first time that research has showed the effect of a particular type of beta-amyloid in the brain, said Dr. Marcello Morrison-Bogorad, director of the division of neuroscience at the National Institute on Aging, to the Associated Press.

He added that the revelation that only one of three types of the proteins had a damaging effect on the brain is important because doctors have long wondered why they find some plaque-covered brains in autopsy that belong to a person who didn't have Alzheimer's.

"A lot of work needs to be done," stated Dr. Morrison-Bogorad, as to why one protein has a damaging effect and not others. "Nature keeps sending us down paths that look straight at the beginning, but there are a lot of curves before we get to the end."

The Harvard study was funded by the National Institute on Aging, Science Foundation Ireland, Wellcome Trust, the McKnight and Ellison foundations and the Lefler Small Grant Fund.

In a separate study out of the Feinstein Institute of Medical Research in New York, Dr. Yousef al-Abed, chief of medicinal chemistry, and his colleagues Michael Bacher and Richard Dodel of Marburg University in Germany created and tested an experimental drug that they say might neutralize or reduce the effects of the beta-amyloid plaques in the patient's brain.

Published in the Journal of Experimental Medicine, the study's results describe an experimental medicine, CNI-1493, already being tested as a medicine for the bowel affliction called Crohn's disease, that targets and transforms amyloid in the brain so that it does not clump and form plaque and also loses its toxicity.

Their results show a 70 to 85 percent reduction of amyloid buildup in the cortex and the hippocampus - the two areas of the brain most affected in Alzheimer's patients and which affect memory, attention, perceptual awareness, language, consciousness and the regulation of emotion.

Heather Chin can be reached at heather.jean.chin@gmail.com

©The Evening Bulletin 2008

Charities Have A Big Year

(previously published here at the bulletin.us)

By: Heather J. Chin, The Bulletin

06/24/2008

Americans gave over $300 billion to charities and nonprofits in the year 2007, according to a study released yesterday, breaking the previous year's total while maintaining the basic overall rate despite economic concerns that included a fallen housing market, struggling credit, high oil and food prices and the ongoing cost of war.

The estimated donation total of $306.39 billion for 2007 included contributions from individuals (at 74.8 percent of the total), foundations (at 12.6 percent), bequests (at 7.6 percent) and corporations (at 5.1 percent), all represented in the annual survey by the Giving USA Foundation, a nonprofit educational organization that researches and publishes data and trends about charitable giving. The rate of charitable giving is reported to have had a strong start at the beginning of the year, before falling back as stock market struggles and housing and credit crisis hit. Data was culled from government sources such as the Internal Revenue Service, the Bureau of Economic Analysis, and the Katrina Emergency Task Relief Act, as well as from panel surveys by the Center on Philanthropy at Indiana University of over 7,800 households about their charitable giving practices.

The study shows that although a record breaker, this year's amount remained at 2.2 percent of the nation's gross domestic product (GDP) - the same level as in 2006, as well as from 2002 to 2004 - and after adjusting for inflation, was only a 1-percent increase over 2006's $294.91 billion.

Still, this made for about an 88 -percent increase from a decade earlier, before individual giving, religious and foundation charitable donations and corporate profits all increased. The many natural disasters around the world that occurred in the last several years also made for a boost in contributions towards relief aid funds.

The high level of individual household giving has primarily been shown through itemized charitable deductions on tax returns for a range of income levels. About 51 percent of this individual giving was from the 10 percent of U.S. households in the highest income groups, while 49 percent came from "ordinary-income donors."

In Giving USA's initial study report, the 2007 pool of charitable contributions were made to a variety of sectors, including religious congregations, which received $102.32 billion (about a third of all donations), educational organizations ($43.32 billion; a 6.4 percent increase), human-services charities ($29.64 billion, an 8.4 percent increase), and health organizations ($23.15 billion, a 5.4 percent increase).

Arts, culture and humanities organizations, as well as international affairs organizations, received an increase in charitable contributions.

The only contribution pool to have received lower levels of giving were private foundations, which fell 9.4 percent to $27.73 billion since 2006.

Heather Chin can be reached at heather.jean.chin@gmail.com

©The Evening Bulletin 2008

Big Pharma Agrees To Stricter Ad Rules

(previously published here at thebulletin.us)

By: Heather Chin, The Bulletin

06/23/2008

Washington - Top drug manufacturers including Johnson & Johnson, Merck and Pfizer agreed last Monday to a six-month moratorium on direct-to-consumer television advertising for new prescription drugs and limitations on how doctors are used in their ads.

The agreements came amid increasing pressure from the Congressional House Energy and Commerce Committee and the American Medical Association (AMA) following earlier controversy surrounding deceptive advertising for anti-cholesterol drugs such as Lipitor, Procrit and Vytorin.

In signed letters, the executive directors of Johnson & Johnson, (J&J), Merck & Co., Merck/Schering-Plough, and Pfizer agreed to take steps towards implementing these recommendations.

Meanwhile, the Pharmaceutical Research and Manufacturers of America (PhRMA) agreed to further meetings with the committee before agreeing to any particular changes at the moment.

All of the companies agreed to adhere to the AMA's guidelines as to the use of actors and health professionals. Specifically, they will continue to identify instances in which an actor portrays a physician, as well as whether the actor was compensated for their appearance. Johnson & Johnson will discontinue use of doctors entirely to discuss the benefits of a drug.

In the letters, each company also stated that the six-month moratorium simply formalized their existing practice of educating doctors before moving to consumer communications.

"We have adopted internal guiding practices on direct-to-consumer advertising for prescription drugs [that] requires our operating companies spend at least six months after approval of a new medicine educating health professionals before commencing a direct-to-consumer advertising campaign," wrote William C. Weldon, chairman-CEO of J&J.

He added that since the advertisements are in line with FDA approved labeling and measures of outcomes, they are an important tool to provide information to patients and physicians, and "a particular fixed period of time for an advertising moratorium is appropriate in all circumstances."

Rep. John Dingell, D-Mich., and Rep. Bart Stupak, D-Mich., chairmen of the committee's oversight and investigations panel, said they were pleased with this response, but wanted the drug companies to adopt the recommended two-year moratorium.

According to Mr. Stupak, he and Mr. Dingell called for the May 8 hearing of the House Energy and Commerce Committee, entitled "Direct to Consumer Advertising: Marketing, Education or Deception?", to both renew pressure and renew the struggle within Congress to strengthen government regulation over such TV commercials. It was also a step towards granting the Food and Drug Administration the right to force changes in the ads before they air.

"Although we appreciate the drug companies' willingness to change some of their business practices, they have not agreed to all of our requests, which would protect consumers from misleading and deceptive advertising," said Mr. Stupak.

Even with these agreements and the potential for future legislation, the debate will go on. Part of that debate lies in the fact that running these ads is mutually beneficial for both the pharmaceutical companies and the TV industry.

Since 1997, when the government relaxed rules on TV and radio ads, pharmaceutical companies shortened the warnings on side effects in their commercials and spent about $14 million on broadcast and cable TV ads for prescription drugs.

In 2007, drug makers spent over $5 billion on direct-to-consumer ads, according to Nielsen Monitor-Plus; more than half of that on television.

"The drug and TV and cable industries have formed a cabal here to protect their revenues," said Gene Kimmelman of Consumers Union, an advocacy group in favor of stricter limits on direct-to-consumer drug marketing.

Ken Johnson, a PhRMA vice president, challenged that in a May article in the Wall Street Journal. He insisted that consumer advertising for prescription drugs "brings patients into their doctors' offices and helps start important doctor-patient conversations about conditions that might otherwise go undiagnosed or untreated."

Still, many consider the ads to be intentionally misleading. "Direct-to-consumer ads often portray drugs through rose-colored glasses by including more information about a drug's benefits than risks," said Dr. Nancy Nielsen, AMA President-elect, in testimony at the congressional hearings.

"Imbalances in these ads can diminish patient understanding of certain drug risks, and increase the need for an ongoing dialogue between patients and physicians about the benefits and risks of prescription drugs," Dr. Nielsen added.

Reporting contributed by AdAge.com and The Wall Street Journal.

Heather Chin can be reached at heather.jean.chin@gmail.com

©The Evening Bulletin 2008

Kimmel Center Gets $10M Grant

(published and archived at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

06/19/2008

Philadelphia - The Kimmel Center received a $10 million grant from the Annenberg Foundation to establish an annual, month-long, themed citywide arts festival, scheduled to being April 2011.

Currently in early planning stages, the festival will bring together all nine Kimmel Center Presents series, the Kimmel Center's resident companies and a wide variety of arts and cultural organizations from throughout Philadelphia. A central theme will unite the participating groups and provide inspiration for new works; the theme for the inaugural festival will be announced at a later date.

"We are thrilled to support such a bold and innovative idea that encourages collaboration among Philadelphia's art organizations," said Gail Levin, executive director of The Annenberg Foundation, "Spotlighting the arts and culture that Mrs. Annenberg has enjoyed and supported for many years in Philadelphia, and sharing it with the world through a citywide arts and cultural festival gives us great pleasure. We hope everyone in the city will embrace this festival and match her incredible generosity."

Through this creative collaboration between the Kimmel Center and the city's arts groups and guest performers, the festival will serve to create a community tradition while spreading awareness of the festival both locally and nationally.

Partnerships between organizations like the Kimmel Center and the Annenberg Foundation will enable Philadelphia to highlight its unique artistic and cultural treasures, as Anne Ewers, president and CEO of the Kimmel Center, anticipates.

"We can shine a bright light on the unique and diverse offerings we enjoy everyday, bring new works to life, and share all of it with Philadelphia and the world."
Heather Chin can be reached at heather.jean.chin@gmail.com

©The Evening Bulletin 2008

MEDICINE: FDA Expands Anti-Psychotic Drug Warning

(published and archived at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

06/18/2008

The U.S. Food and Drug Administration (FDA) will soon be increasing the number of prescription anti-psychotic drugs to carry a special warning label.

The label will warn against side effects, particularly for those over 65 based on recent studies suggesting the elderly are susceptible.

Several older or "conventional" antipsychotic medications used to treat behavioral and dementia-related problems are scheduled to join other newer drugs in carrying a "black box" warning.

The FDA's Web site lists Navane, Haldol and Moban among 11 conventional drugs affected by the new regulations.

Pharmaceutical manufacturers will have 30 days to submit either the wording for the new labels or a reason to dispute the FDA's labeling requirement. After that point, the FDA will have authority to enforce the legal requirement.

Although antipsychotic drugs are not approved to treat dementia, and are primarily utilized for schizophrenia, studies found that patients with dementia who take these drugs can exhibit violent behavior.

The decision whether or not to prescribe these medications is and will remain up to the prescribing doctor on a case-by-case basis.

Symptoms of dementia range from forgetfulness and diminished memory to an inability to recognize familiar objects, sounds or people.

In 2005, the FDA first announced requirements for black box warnings for the newer, or "atypical" antipsychotic drugs. These drugs with existing warning labels include Abilify, Clozaril, Risperdal, Seroquel and Zyprexa. These drugs tend to cause a lower incidence of side effects, such as involuntary tics and parkinsonism. Parkinsonism is the display of symptoms similar to, but not necessarily symptomatic of Parkinson's disease, including tremors slow movement, impaired speech or muscle stiffness.

In a news conference on Monday, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, said that the warning is intended to help doctors and families understand and balance the risks and benefits of anti-psychotic medication.

"It is important that health care professionals and consumers have the most up-to-date drug safety information," said Dr. Laughren.

In the two studies on which the box warnings are now based, researchers found patients taking the older drugs had a 4.5 percent risk of death, versus a 2.6 percent risk for those taking a placebo.

Dr. Laughren speculated however, that as the patients in the studies were elderly and many were already ill, its findings might be biased.

©The Evening Bulletin 2008

"Smashing Pumpkins" Sue Virgin Records

Written by: Heather Chin

(Previously published on March 25, 2008 @ http://thecelebritycafe.com/features/14832.html)

The hit rock group is suing the major record company, claiming illegal use of their name and reputation.

The New York Times and the AP report that longtime rock band, Smashing Pumpkins, is suing their record label for allegedly using their name and music without consent, thus illegally, and in the process, hurting the band’s credibility with fans.

The lawsuit filed in Los Angeles Supreme Court on Monday, cites “breach of contract.” Band members stated that they have “worked hard for over two decades to accumulate a considerable amount of goodwill in the eyes of the public,” and that their reputation for “artistic integrity” was threatened by Virgin’s use of their music in promotional ads for Pepsi Co. and Amazon.com.

Although Virgin has distributed Smashing Pumpkins’ records for over 17 years, the lawsuit claims that there was never any agreement or “authority granted to Virgin, or any other entity,” to use either the music or the band in any promotional campaigns for outside products. The band maintains that the only active agreement made was a deal with Virgin to sell digital downloads of Smashing Pumpkins songs.

The lawsuit demands that Virgin pay the band with the profits that were earned in the contested promotions.