NSBRI, Sep. 26, 2008 — Self-guided treatment for depression could soon be only a mouse click away.

Scientists with the National Space Biomedical Research Institute (NSBRI) are developing an interactive, multi-media program that will assist astronauts in recognizing and effectively managing depression and other psychosocial problems, which can pose a substantial threat to crew safety and mission operations during long-duration spaceflights.

Even though the depression treatment is under development for NASA, project leader Dr. James Cartreine said it could be spun off for use on Earth.

“This project has great potential as a self-guided treatment for many people,” said Cartreine, a member of NSBRI’s Neurobehavioral and Psychosocial Factors Team. “Depression is the number one cause of disability days in the United States, but it’s not only about days lost. Depression also results in presenteeism – showing up for work but not really working.”

The depression treatment is part of the Virtual Space Station, a multi-media program that addresses multiple types of potential psychosocial problems and can be used for training before, and for assistance during, missions. Other problems being addressed via the Virtual Space Station include interpersonal conflict, and stress and anxiety.

Cartreine, a Harvard Medical School research psychologist based in the Division of Clinical Informatics at Beth Israel Deaconess Medical Center in Boston, said the Virtual Space Station will make effective therapeutic depression treatment more easily accessible to astronauts aboard the International Space Station and proposed missions to the moon and Mars. Currently, astronauts have audio and video access to psychologists only when communication links are available.

Project co-investigator and former astronaut Dr. Jay Buckey said long-duration spaceflight can be tough on astronauts. “While astronauts are not particularly prone to psychological problems, the environment is very demanding,” Buckey said. “On a mission, they face a lot of challenges that could lead to depression.”

Buckey, a professor and physician at Dartmouth Medical School, said the depression module and other aspects of the Virtual Space Station are based upon proven methods. “These are unique NSBRI products that did not exist before,” Buckey said. “The Virtual Space Station is based on proven treatment programs and is a very helpful way to work on problems in general.”

The system’s multi-media approach for depression includes graphics and video featuring a psychologist who leads the user through a straightforward process called Problem-Solving Treatment. The system provides feedback based upon the information provided when answering a series of questions.

The first step of the process is to make a problem list and select a problem on which to work. The second and third steps are setting goals and brainstorming ways to reach them. The final two steps are assessing the pros and cons of possible solutions and making an action plan to implement them. The program also helps users plan and schedule enjoyable activities, which people who have depression often stop doing. Additionally, the program provides preventative and educational information on depression.

Cartreine and Buckey, who received input from 29 current and former astronauts while designing the Virtual Space Station, said some of the system’s other benefits include its portability and privacy. “It can be delivered to the International Space Station on a flash drive and run directly from that drive, so that the astronaut has complete control over his or her data,” Cartreine said. “The system is private and secure. The user is the only one who can share the information with others.”

An early version of the depression treatment system was beta-tested on research stations in Antarctica, which is used as an analog to long-duration spaceflights due to its isolation from the rest of the world, length of stay and team composition. Cartreine said feedback from that early test run has been positive, and a clinical evaluation of the latest version on 68 Boston-area volunteers is about to begin.

“We plan to study the program’s ability to treat depression,” he said. “We are looking for people who are similar to astronauts, such as people in the technology industry.”

Eventually, the researchers want to adapt the system for use in many different settings, giving people access to treatment they may not have now. For instance, people with depression often seek treatment by going to their primary care physician, so the researchers hope to adapt it for use at the doctor’s office or in a person’s home.

The system could also be beneficial in rural areas where clinical help is in short supply or nonexistent. Other possible locations for use include schools, social service offices, places of worship, military bases, prisons, commercial ships, oil rigs and underwater research stations.

The self-guided treatment project is part of the NSBRI Neurobehavioral and Psychosocial Factors Team portfolio, which includes studies on and development of countermeasures for stress, anxiety, interpersonal conflict and fatigue.

Content on stress and anxiety management for the Virtual Space Station is being developed by Dr. Raphael Rose at UCLA. Harvard Medical School and Massachusetts General Hospital researcher Dr. Gary Strangman is studying the depression treatment program’s effects on brain activity using infrared imaging.

Adapted from materials provided by National Space Biomedical Research Institute.

Mayo Clinic Health Letter — Aristotle and Hippocrates believed in the power of images in the brain to enliven the heart and body. Today, research shows they were right. Guided imagery is helping patients use the full range of the body’s healing capacity.

Guided imagery is more than listening to relaxing sounds. It’s a learning process to listen to someone’s voice, relax the breathing and consciously direct the ability to imagine. The effect of guided vivid imagery sends a message to the emotional control center of the brain.

From there, the message is passed along to the body’s endocrine, immune and autonomic nervous systems. These systems influence a wide range of bodily functions, including heart and breathing rates and blood pressure.

Guided imagery has been shown to benefit patients by:

* Reducing side effects from cancer treatment
* Reducing fear and anxiety prior to surgery. Studies have shown that surgery patients who participated in two to four guided imagery sessions required less pain medication and left the hospital more quickly than those who hadn’t used imagery.
* Managing stress
* Managing headaches. Studies have shown that guided imagery may aid in reducing the frequency of migraine headaches as effectively as taking preventive medications.

Adapted from materials provided by Mayo Clinic

September 26, 2008 — Calorie restriction, a diet that is low in calories and high in nutrition, may not be as effective at extending life in people as it is in rodents, according to scientists at Washington University School of Medicine in St. Louis.

Previous research had shown that laboratory animals given 30 percent to 50 percent less food can live up to 50 percent longer. Because of those findings, some people have adopted calorie restriction in the hope that they can lengthen their lives. But the new research suggests the diet may not have the desired effect unless people on calorie restriction also pay attention to their protein intake.

In an article published online this month in the journal Aging Cell, investigators point to a discrepancy between humans and animals on calorie restriction. In the majority of the animal models of longevity, extended lifespan involves pathways related to a growth factor called IGF-1 (insulin-like growth factor-1), which is produced primarily in the liver. Production is stimulated by growth hormone and can be reduced by fasting or by insensitivity to growth hormone. In calorie-restricted animals, levels of circulating IGF-1 decline between 30 percent and 40 percent.

“We looked at IGF-1 in humans doing calorie restriction,” says first author Luigi Fontana, M.D., Ph.D., assistant professor of medicine at Washington University and an investigator at the Istituto Superiore di Sanità in Rome, Italy. “For years, we have been following a cohort of people from the CR Society who have been on long-term calorie restriction. We found no difference in IGF-1 levels between people on calorie restriction and those who are not.”

The CR Society members, who call themselves CRONies (Calorie Restriction with Optimal Nutrition), had been on a calorie-restriction diet for an average of seven years when Fontana did the measurements, but their IGF-1 levels were virtually identical to sedentary people who ate a standard, Western diet.

Because calorie restriction is linked to extraordinary increases in maximal lifespan in rats and mice, Fontana and colleagues at Washington University, including principal investigator John O. Holloszy, M.D., professor of medicine, have been involved in a scientific study that compares calorie restriction to exercise and measures many biological factors linked to longevity and health. Called the CALERIE study (Comprehensive Assessment of the Long term Effects of Reducing Intake of Energy), the project randomly divided 48 people into three groups: Eighteen cut their caloric intake by 25 percent for one year. Another 18 started exercising to increase their energy expenditure by 25 percent for a year. A third group of 10 people didn’t change anything.

At the end of that year, the investigators measured IGF-1 levels in all three groups. Again they found no reductions in the group on calorie restriction.

“That was puzzling because it was the first time we hadn’t seen agreement between mice and rats on calorie restriction and humans on calorie restriction,” Fontana explains. “But we know there are two major influences on IGF-1 levels: calorie intake and protein intake. So we decided to look at the influence of protein.”

Again, Fontana had a ready-made study group. His team has been following a population of strict vegans for several years. They tend to eat less protein than the CRONies from the CR Society, so he compared IGF-1 levels between the two groups.

“The vegans had significantly less circulating IGF-1, even if they were heavier and had more body fat than CRONies,” he says. “Protein in the diet seemed to correlate with the lower levels of IGF-1. The strict vegans took in about 10 percent of their total calories from protein, whereas those on calorie restriction tended to get about 23 or 24 percent of calories from protein.”

The investigators wanted to take one more look at the relationship between dietary protein and IGF-1, so Fontana asked a group of CRONies to eat less protein for a few weeks. He says it was not easy to cut protein because those on calorie restriction have to do a lot of calculating and juggling to ensure they take in very few calories and still get adequate nutrition. Increasing dietary protein is one way many CRONies guard against becoming malnourished.

“But six of them agreed to lower their protein intake,” Fontana explains, “and after three weeks their circulating IGF-1 declined dramatically.”

Previous research from Fontana’s group had found that a diet lower in protein might protect against some cancers. These more recent findings suggest lowering protein also might be important to longevity. Fontana admits his evidence is preliminary, but the findings suggest that when people adjust their diets to improve health and lengthen life, they should control not only calories and fat but also keep an eye on protein.

Fontana isn’t proposing radical low-protein diets. Instead, he is suggesting the current recommended daily allowance (RDA) for protein, which is 0.82 grams of protein per kilogram of body weight, or about 56 grams of protein for an average, adult man and 46 grams for an average, adult woman. Most people, including CRONies, consume much more protein than the RDA recommendation.

“It’s much easier to restrict protein than to restrict calories,” he says. “If our research is on the right track, maybe humans don’t need to be so calorie restricted. Limiting protein intake to .7 or .8 grams per kilogram per day might be more effective. That’s just a hypothesis. We have to confirm it in future studies.”

Until then, Fontana suggests people might want to look at protein consumption and tailor it to RDA recommendations. Traditionally, he says, nutritionists have not worried about people eating too much protein, but these findings suggest perhaps they should.

Journal references:

1. Fontana et al. Long-term effects of calorie or protein restriction on serum IGF-1 and IGFBP-3 concentration in humans. Aging Cell, 2008; 7 (5): 681 DOI: 10.1111/j.1474-9726.2008.00417.x
2. Fontana L, Klein S, Holloszy JO. Long-term low-protein, low-calorie diet and endurance exercise modulate metabolic factors associated with cancer risk. American Journal of Clinical Nutrition, vol. 84; pp. 1456-1462, Dec. 2006

Adapted from materials provided by Washington University School of Medicine

‘Mitochondrial Eve’ Research: Humanity Was Genetically Divided For 100,000 Years

Researchers believe that about 60,000 years ago, modern humans started their epic journeys to populate the world. This time period has been the primary focus of anthropological genetic research. However, relatively little is known about the demographic history of our species over the previous 140,000 years in Africa. The human race was divided into two separate groups within Africa for as much as half of its existence, says a Tel Aviv University mathematician. Climate change, reduction in populations and harsh conditions may have caused and maintained the separation. Dr. Saharon Rosset, from the School of Mathematical Sciences at Tel Aviv University, worked with team leader Doron Behar from the Rambam Medical Center to analyze African DNA. Their goal was to study obscure population patterns from hundreds of thousands of years ago. Rosset, who crunched numbers and did the essential statistical analysis for the National Geographic Society’s Genographic Project, said the team was trying to understand the timing and dynamics of the split into at least two separate groups. “We wanted to look into the ancient history of our species. How did we live throughout most of our existence as a species? Did we live as one — or were we fractured into small groups? Until now, it wasn’t really clear,” says Rosset. The current study returns the focus to Africa and thereby refines the understanding of early modern Homo sapiens history. Rosset, who is also affiliated with IBM’s T.J. Watson Research Center in New York, says the study provides insight into the early demographic history of human populations before they moved out of Africa. “These early human populations were small and isolated from each other for many tens of thousands of years,” says Rosset. The team’s research was based on a survey of African mitochondrial DNA (mtDNA) and is the most extensive survey of its kind. It included over 600 complete mtDNA genomes from indigenous populations across the continent. MtDNA, inherited down the maternal line, was used in 1987 to discover the age of the famous “Mitochondrial Eve,” the most recent common female ancestor of everyone alive today. This work has since been extended to show unequivocally that “Mitochondrial Eve” was an African woman who lived sometime during the past 200,000 years. Recent data suggests that Eastern Africa went through a series of massive droughts between 90,000 and 135,000 years ago. It is possible that this climate shift contributed to the population splits. What is surprising is the length of time the populations were separate — for as much as half of our entire history as a species. Dr. Spencer Wells, director of the Genographic Project and Explorer-in-Residence at the National Geographic Society, said, “This new study illustrates the extraordinary power of genetics to reveal insights into some of the key events in our species’ history. Tiny bands of early humans, forced apart by harsh environmental conditions, coming back from the brink to reunite and populate the world. Truly an epic drama, written in our DNA.

As part of the commitment to efficient and effective paperless clinical trials, Target Health will be releasing Target e*CTMS in early October. Target e*CTMS will be residing in our new portal and will take a clinical trial from “cradle to grave.” There will be project management, financial management and even the ability to draw data from other EDC applications. We are building the software collaboratively with another CRO, confirming that we are the only eCRO to CROs.

For more information about Target Health or any of our software tools for clinical research, please contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Our software tools are designed to partner with both CROs and Sponsors.

In addition to pruning cells out of the way during embryonic development, the much-studied process of programmed cell death, or 1) ___, has been newly found to exert significant mechanical force on surrounding cells. This mechanical force may be harnessed throughout biology by tissues to aid wound formation, organ development and other processes that require cell movement, according to a Duke University team that melds biology with physics to investigate force at the 2) ___ level. Cells are known to move in coordinated fashion during the closure of an eye-shaped opening on the back of a developing fruit fly embryo, a model system Duke biophysicists have been working on for nearly a decade. The newly discovered 3) ___ created by apoptotic cells imploding and withdrawing is making a force sort of like a friend helping you tuck the edge of the sleeping bag in. Dying cells appear to occur at random times across the plane of cells comprising the shrinking opening, in a pattern that totals about 10% of the population of cells. It was first hypothesized that the apoptotic 4) ___ might be particularly significant for force production. The next step was to carefully measure the motion of cells immediately surrounding a dying cell. What was observed by laser-induced fluorescence, was that as a dying cell collapsed and sunk beneath the surface, it contributed to the 5) ___ pulling the edges of the opening closer together. It was concluded that apoptosis is not a single cell event but is amplified by the five-to-seven surrounding cells. On balance, these dying cells exert perhaps a third to a half of the force that is moving the edges of the opening together, so it’s a very significant part of the 6) ___. The forces at work here are measured in perhaps billionths of a Newton, but that’s because you’re moving cells, [one pound = 4.45 newtons]. At the cellular scale, these forces are quite substantial. The group’s findings appear in the Sept. 19 edition of Science. Though this finding is so far limited to dorsal closure in the fruit fly embryo, next steps are to begin looking for the mechanical force of apoptosis elsewhere. Earlier findings on the fruit fly model so far have appeared applicable to wound closure and organ development in vertebrates like humans. It’s entirely possible, that evolution has harnessed the 7) ___ force created by dying cells in many other ways.

ANSWERS: 1) apoptosis; 2) cellular; 3) force; 4) cells; 5) forces; 6) process; 7) mechanical

The New York Times, by Pauline W. Chen MD, Sept 25, 2008 – I would like to believe that I am a compassionate doctor. But when I must convey bad news to a patient, one of the first things I worry about is time.

One of the most challenging, and potentially rewarding, aspects of being a doctor is responding and acknowledging patients’ fear, anger, frustration and sadness. But I have always believed that it takes more time to listen and answer empathetically — time that is hard to ignore when you know there are other patients who have been waiting a long time outside to see you.

A paper this week in a medical journal, though, has made me think a little differently about time and empathy. The study, in The Archives of Internal Medicine, found that physicians overwhelmingly miss opportunities to express empathy to their patients.

Listening to transcripts and recordings of 20 conversations between men with lung cancer and their doctors, Dr. Diane Morse of the University of Rochester School of Medicine and her colleagues identified 384 “empathic opportunities” in the discussions — moments when a doctor might respond with a few words to address patient concerns ranging from fear of illness and death, to mistrust about care and the health care system, to confusion about treatment.

They found that the physicians missed 90 percent of opportunities to respond empathetically to their patients.

One of the reasons for this staggering statistic, the investigators suggest, is lack of time. “In a busy clinic,” the authors wrote, “physicians may believe that there is no time for empathic responses.”

As I read the paper, I remembered one particular afternoon in clinic spent with a man in his late 50s who had liver cancer.

The man, wiry and stooped, had immigrated some 30 years earlier and had worked in restaurants in the Los Angeles area. Accompanying him was his daughter, a radiant 20-something graduate student who spoke comfortably, confidently, in the English that was her first language.

She had researched her father’s diagnosis on the Internet and had arranged to have him seen in our clinic. She wanted to know if we could take out her father’s tumor.

After examining her father, I stepped out of the room to join the other surgeons viewing his CAT scans. As we crowded around the pictures, the tumor emerged — a dark circle in the middle of the man’s liver. View after view, the circle seemed only to widen, an ominous black hole that threatened to swallow what little normal liver was left.

I wanted to scream for the man and his daughter. Instead, I whispered a series of expletives directed at the tumor, then stepped back into the examining room, bracing myself for what would be a hard and, I believed, long conversation. I had to tell this family that the tumor was inoperable.

I had had these kinds of conversations in the past and could only imagine how difficult it would be for this patient and his daughter. I wanted to be compassionate with them, to take the time to listen and to acknowledge their fears and concerns.

But I also did not want to open the floodgates of emotion on an afternoon when the waiting room was overflowing.

In the end, I decided to take the time to listen to the man and his daughter, to ignore for a few moments the clock on the wall.

What surprises me, reflecting back on that interaction, is that despite all the questions and moments of deep emotion that came up during our conversation, the entire visit did not take nearly as long as I had imagined it would. And clinic that afternoon did not run any later than usual.

It did not take more time to be open to the man and his daughter’s emotional needs and to acknowledge them with a few words.

The results of Dr. Morse’s study have already made their way onto the Internet. “For Some Doctors, Empathy Is in Short Supply,” the headlines read.

But the statistic about doctors’ missed empathic opportunities is not, I believe, what is so intriguing about her study.

What is most interesting — and, I believe, most important — about this study is that empathy, expressed throughout a patient-doctor encounter, may actually help to alleviate problems with time.

Or at least not exacerbate them to the extent that many doctors, including myself, fear.

Dr. Morse and her colleagues found that while patients brought up important emotional issues throughout a visit, their doctors tended to express the bulk of their empathy toward the end of that visit.

When doctors did not respond to initial opportunities to be empathetic, patients would try repeatedly, throughout the rest of the visit, to elicit that support in some way.

In other words, too little empathy, or empathy expressed too late in an encounter, may actually result in longer visits.

When the doctors did respond in a way that explicitly recognized patient emotions, patient responses were not long, as some of us might imagine. Instead, patients usually responded with one or two words, or a single sentence.

There is, then, no floodgate.

Not long after I spoke to that man with liver cancer in clinic, I received a note from his daughter:

I just wanted to say thank you deeply for all your assistance and care regarding my father. Finding out my father has cancer has consumed me and my family emotionally and physically. Meeting you and the entire team calmed my heart more than you can know.

We had finished our visit in time, and it was, I believe, worth every minute.

“Do Doctors Have Time for Empathy?” Join the discussion on the Well blog. And to read more on doctors, empathy and end-of-life care, visit The New Old Age blog, on Dr. Diane E. Meier, recent winner of a MacArthur Foundation “genius award.”

Pauline W. Chen, a liver transplant surgeon, is the author of “Final Exam: A Surgeon’s Reflections on Mortality” (Knopf, 2007; Vintage, 2008). Her online column, “Doctor and Patient,” appears Thursdays on nytimes.com/health.

September 25, 2008, PharmaLive.com — Seniors who switch between low-cost generic drugs and the original products based on who’s footing the bill are likely driving up the cost of the government’s Medicare drug plan, according to a new study.

Figures released Thursday show seniors are more likely to ask their pharmacist for generic medications when they are paying, but choose the more expensive originals when the government is covering the costs.

The study was published by Medco Health Solutions Inc., a drug benefit manager that handles prescriptions for about 20 percent of Americans. Prescription benefit managers earn more money when patients choose cheaper medications.

While the Medicare drug benefit has pushed up the country’s overall health care spending, the program’s budget has actually come in below estimates, which federal officials attribute to a greater use of generic drugs and competition among insurance companies.

Generic drugs are medically indistinguishable from the original products, and can cost up to 80 percent less. They account for two-thirds of all prescriptions dispensed in the U.S, according to research firm IMS Health.

However, the figures from Medco suggest some patients are still more comfortable taking medicines from the original manufacturer.

“It may be a question of education, that some people simply believe brand-name drugs work better than generics,” said Tricia Neuman, a vice president with the Henry J. Kaiser Family Foundation. Research also shows that doctors often don’t talk about the potential cost savings of generic drugs, she added.

Kaiser, a nonprofit research group, estimates the average out-of-pocket expense for seniors in Medicare taking generic drugs will be $5.32 this year, nearly six times less than the $29.86 paid by seniors taking branded drugs listed by insurers.

Despite the potential cost savings, Medco found that nearly two-thirds of prescriptions initially filled by patients in Medicare were for branded medications.

The majority of seniors only switched to generics after they reached the point in spending when users must pick up the whole cost of prescriptions.

“Medicare beneficiaries become acutely aware of the cost difference between brand-name and generic drugs and most make the switch,” said Medco Chief Medical Officer Woody Eisenberg.

But Medco also found that when seniors’ drug costs reached the “catastrophic” phase and are again covered by Medicare, 59 percent of prescriptions are for branded drugs.

An official from the federal Centers for Medicare and Medicaid Services said the agency could not confirm the figures cited by Medco.

Overall, the federal government and beneficiaries through their monthly premiums will spend about $47 billion on the Medicare drug benefit this year.

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Congress Debates Bottled Water

Critics Tell Lawmakers Bottled Water Hurts Environment; Industry Says Consumers Deserve Choices

Reviewed by Louise Chang, MD

WebMD Health News, by Todd Zwillich, September 2008 — Environmental and consumer groups are urging closer scrutiny of bottled water. The groups say Americans are wasting billions of dollars while causing environmental damage — and adding few health benefits.

The calls come as Congress begins to consider stricter labels that alert consumers about the source and potential environmental impact of the products.

“The public should not assume that water purchased in a bottle is better regulated, more pure, or safer than most tap water,” says Mae Wu, an attorney with the Natural Resources Defense Council.

Wu and others made their comments to lawmakers at a hearing on Capitol Hill.

Close to 40% of bottled water sold in the U.S. comes from municipal sources, the same place tap water comes from. Wu says nearly all public tap water is filtered before it’s distributed to homes and businesses.

Wenonah Hauter, who heads the consumer group Food and Water Watch, says a gallon of bottled water can cost between $8 and $10 in some areas — twice the cost of gasoline.

“Especially today, with the downturn in the economy, people have only so many dollars to spend at the grocery store. And if they’re spending that money on bottled water instead of perhaps fruit or vegetables for their family, then we think that’s probably not the best decision,” she says.

Cities and Tap Water

Some cities have confronted concerns over the safety of their water supply. One is Washington, D.C., which moved to replace thousands of feet of water pipes after high lead levels were detected in city water.

But other cities have staged campaigns to promote tap water consumption and steer residents away from bottled water, which city officials say can be a burden to local waste management authorities.

New York City recently completed a nearly $1 million effort promoting the high quality of the city’s water supply, which is one of a handful in the country that does not need treatment to meet federal health standards. The city gave out 50,000 reusable water bottles to residents.

“One of the goals of the campaign was to address the myth that tap water is somehow not as safe or desirable as bottled water or sweetened beverages,” says Emily Lloyd, commissioner of the New York City’s Department of Environmental Protection.

Stephen Edberg, PhD, a water researcher and professor of medicine at Yale University, told lawmakers bottled water poses some advantages over local tap water.

“It’s sealed, and that’s it. Nothing else happens,” he says. Tap water, on the other hand, can be subject to “great variability” as it moves from the source to treatment facilities to homes, he says.

Edberg said bottled water can be an advantage for people with compromised immune systems, including cancer patients, those taking some arthritis drugs, and patients with HIV.

Sen. Frank Lautenberg, D-N.J., introduced a bill Wednesday requiring water bottle labels to carry information about the quality and source of the water inside. “Consumers have a right to know,” he says.

Joseph Doss, who heads the International Bottled Water Association, says his industry is stepping up efforts to encourage plastics recycling and to make bottle production more fuel efficient. Water bottles account for 0.3% of all solid waste produced in the U.S., according to the industry.

“Any actions that would discourage consumers from drinking this safe, healthy beverage are not in the public interest,” he says.

Americans spend about $11 billion per year on bottled water, according to the Beverage Marketing Corp. In the process they help generate 2.7 million tons of plastic bottles. Those bottles are produced and transported using petroleum, and most wind up in landfills, Wu says.

Doss says bottled water is already closely regulated as a food product by the FDA.

“I guess it comes down to choice, and consumers have a choice,” he says.

PharmaLive.com, September 25, 2008 – Eli Lilly and Co. aims to grow leaner and more diverse as it pushes to keep pace with changes spreading through the drug industry, CEO John Lechleiter said in a Wednesday afternoon speech.

Biotechnology drugs that can be tailored more closely to individual patient needs and networks that speed drug development will become keys for Lilly as it approaches the patent expiration dates for several top sellers.

“We’re flat-out rejecting the conventional wisdom that says it must take 10 to 15 years, and a billion dollars-plus, to bring a single new molecule to patients,” Lechleiter said in a luncheon speech for The Economic Club of Indiana.

Lechleiter, who became CEO in April, touched on several topics as he outlined the company’s future for a hometown audience.

“We’re still a proud, Indiana-based company, but folks, this is not your grandfather’s Lilly,” Lechleiter said. “It can’t be anymore.”

The company also announced last week that Lechleiter, 55, will become chairman next year, replacing former CEO Sidney Taurel in that role too.

Lilly’s total employment ballooned from 30,000 to about 46,000 in the late 1990s and early part of this decade. It has since retreated back below 40,000 mostly through attrition and some buyouts, and Lechleiter said the company will continue to push that total down. But he did not offer specific goals for total jobs.

Meanwhile Lilly plans to expand networks with other companies that lead to drug developments through partnerships or alliances. The CEO noted that the U.S. Food and Drug Administration approved only 19 new medicines last year, the lowest annual total since 1983.

“Lilly cannot succeed as an innovator in the 21st century if we’re maintaining capacity we no longer need or undertaking tasks that others can perform better or for less,” he said.

Major acquisitions or mergers don’t make sense for Lilly, Lechleiter said. But the drug maker does plan to bulk up its animal health business with smaller-scale deals.

Biotechnology products, which are developed from living cells instead of chemical compounds, already account for about a third of Lilly’s annual revenue, which totaled $18.6 billion last year. But Lechleiter wants these drugs to account for more so the company can tailor medicines to better treat disease variations or patient groups.

Biotech molecules also are less susceptible to generic competition than chemical compounds because of the complexity of their manufacture.

Lilly spent $1 billion to develop a biotech center in Indianapolis and started building a new biotech manufacturing site last April in Ireland.

Lilly’s stock price soared past $100 in 2000 but has dropped considerably since then. Shares sold for $46.16 Wednesday, and they could take another hit Friday, when the FDA is expected to decide the fate of the cardio drug prasugrel.

Lilly and its Japanese partner, Daiichi Sankyo Co., hope to gain approval of the drug to treat patients with acute coronary syndromes, such as heart attacks or unstable angina, who are at risk of developing blood clots.

Analysts, who have expressed concern about the depth of Lilly’s product pipeline, say the drug could eventually bring in more than $1 billion in annual sales.

Lilly could use a new blockbuster. The patent protecting its top-selling drug, anti-psychotic Zyprexa, expires in 2011. The one covering its second-largest seller, the antidepressant Cymbalta, expires in 2013.

Lechleiter said before his talk Wednesday these looming expirations offer motivation for the company’s changes. But he also noted that patent expirations are part of the business cycle of a drug company.

Broader problems like the cost of developing drugs and the decrease in new drug approvals play more of a role in Lilly’s strategy.

“I do believe what’s going on in our industry right now is more fundamental than that, and we have to respond to it,” he said.

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Pfizer R&D Head Sees More Drug Collaborations

PharmaLive.com, September 25, 2008 – – Pfizer Inc’s research chief said he foresees more collaborations with other pharmaceutical companies in an effort to share the cost and risk of drug development and potentially get more experimental medicines into expensive late stage testing.

“I certainly would like to do more,” Martin Mackay, Pfizer’s global head of research and development, said on Wednesday at a pharmaceutical conference in Manhattan.

Pfizer is already involved in a co-development collaboration with Bristol-Myers Squibb Co on the experimental blood clot preventer apixaban from a highly anticipated new class of medicines that has been targeted by several drugmakers.

Some investors dislike such risk-sharing deals as any profit that comes from a successful new drug must be shared.

But Mackay has been so pleased with the Bristol arrangement that it has whetted his appetite for more.

“The apixaban deal has been terrific. It’s an excellent collaboration,” said Mackay, who was taking part in a panel discussion along with the research heads of Eli Lilly & Co, Wyeth and Johnson & Johnson at the Windhover Pharmaceutical Strategic Alliances conference.

“I think it has exceeded both teams’ expectations,” he said. “When we put them together we found more synergies than I certainly had anticipated.”

Such collaborations could help medicines and molecules that might otherwise languish in limbo eventually see the light of day.

“Like most of us, we have this burgeoning phase 2 pipeline which is beginning to move into phase 3, probably too many for the budget than we have, healthy as that is,” Mackay said, referring to the world’s largest drugmaker’s more than $7 billion annual R&D budget.

Phase 3 is typically the final stage of human testing before a new drug is submitted to regulators for an approval decision and involves large, extremely expensive clinical trials. So decisions on which drugs to move forward into phase 3 are as critically important as any a drug company makes.

Steven Paul, head of Lilly’s research labs, said he would love to have back some of the drug candidates they decided to pass on, which have turned out to be successful.

Mackay said Pfizer would be looking at collaboration opportunities even on drugs that are not yet nearing the critical phase 3 decision.

“I would like to be more creative about our assets, not just in the late stages but in earlier stages too,” he said.

“I see us outlicensing more of our assets and being creative about the deal making terms,” Mackay said.

Given the disturbingly high failure rate of experimental medicines — 70 to 75 percent of all phase 2 drugs by Paul’s account — all the panelists agreed that creative risk-mitigating strategies are necessary going forward.

Wyeth R&D chief Mikael Dolsten saw one more advantage of collaborative arrangements with other drugmakers.

“It’s also a way of getting access to new talent without hiring them,” he said.

The New York Times, September 25, 2008 – Amid a national debate over the influence of industry money on medical research and practice, two pharmaceutical giants say they will begin publicly reporting payments they make to outside doctors.

John C. Lechleiter, chief executive of Eli Lilly & Company, announced on Wednesday that starting next year it intended to post in an online database all its payments to doctors for speaking and consulting services. The postings will ”likely include” the names of the doctors, or will provide some other identifying information about them, along with the reason for the payments, the company said.

In the wake of Lilly’s announcement, Merck & Company said later Wednesday that it would disclose speaking fees it pays to doctors, also beginning in 2009.

Members of Congress have been pushing for a national registry of such payments. In the last year and a half, Senate investigations have found that prominent researchers at several institutions, including Harvard and the University of Cincinnati, failed to report millions of dollars in outside income from drug makers, contrary to the institutions’ reporting requirements.

University administrators and journal editors say they have no reliable way to verify doctors’ private income from industry. Research has found that industry money can bias doctors’ interpretation of study findings and may alter their prescribing habits.

A bipartisan bill called the Physician Payments Sunshine Act, expected to be taken up by Congress next year, would require such a registry. The Pharmaceutical Research and Manufacturers of America, the industry’s principal trade group, supports the legislation, as do the American Medical Association and a number of major drug makers.

”Though we remain hopeful that the Sunshine Act will be passed by Congress at some point, Lilly is taking action independently,” Dr. Lechleiter said Wednesday in a speech to the Economic Club of Indiana. ”Being more transparent by opening up our business to the public is an important step to building trust and confidence.”

A Lilly spokesman said the company hoped others would follow its lead, a wish voiced by some independent experts.

”This is a good step, and one that should be emulated by other companies, even in the absence of legislation requiring it,” Dr. Paul S. Appelbaum, a professor of psychiatry, medicine and law at Columbia University and the New York State Psychiatric Institute, said in an e-mail message.

Dr. Appelbaum said the simplest way to achieve comprehensive disclosure was for the industry itself to maintain public records. ”Any physician who believes that disclosure is likely to be embarrassing,” he said, ”should not be accepting the money in the first place.”

As of late Wednesday, Merck was the only other drug company to have joined Lilly in announcing plans for disclosure of such payments.

A spokesman for Johnson & Johnson said on Tuesday that the company supported a revised version of the Sunshine Act and had committed to disclosing payments for educational grants and to patient-advocacy organizations by early 2009.

A spokesman for AstraZeneca said that it already posted educational grants and contributions to nonprofits but that it had not made a decision ”on other areas just yet.”

A spokesman for Pfizer said it supported the Sunshine Act.

Lilly was the first drug maker to publish extensive clinical trial data online, beginning in 2004, and last year it began posting its educational grants and charitable contributions online. Its new database will record all payments it makes to doctors on or after next Jan. 1, and will be accessible online in June or July. If Congress passes a law requiring such reporting, the information will be brought into line with federal guidelines, the company said.

Through a spokeswoman, Senator Charles E. Grassley, Republican of Iowa, who has been leading the investigations into drug companies’ payment practices, said: ”Disclosing information about financial relationships between industry and doctors is a good thing, and this announcement contributes to transparency. My effort for broad-based transparency and accountability will continue because a uniform reporting requirement is needed to get the full picture.”

Drug companies’ payments to doctors generally fall into one of two broad categories: speaking fees, to doctors who give presentations about products to other doctors, very often while the group dines at the company’s expense; and consulting fees, to experts who advise the company on new product development or help design clinical trials.

Commercial arrangements are common throughout medicine. In the last two decades, drug and device makers have made payments to tens of thousands of doctors and researchers in all specialties. Worried that this money could taint doctors’ research plans or clinical judgment, government agencies, medical journals and universities have been looking more closely at the deals.

Minnesota and Vermont are among the few states that have been keeping a record of those payments. From 1997, when Minnesota began its database, to 2005, drug makers made payments to more than 5,500 doctors, nurses and other health care providers in the state, totaling at least $57 million, the state found. An additional $40 million went to clinics, research centers and other organizations. More than 20 percent of the state’s licensed physicians received money.

Vermont reported last year that from July 2005 to June 2006, 81 drug manufacturers spent a total of $2.25 million on ”fees, travel expenses and other direct payments to Vermont physicians, hospitals, universities and others for the purpose of marketing their products.”

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Merck, Japan Tobacco in Osteoporosis Drug Deal

PharmaLive.com, September 25, 2008 – Merck & Co Inc and Japan Tobacco Inc said they signed a worldwide licensing agreement for JTT-305, an investigational oral bone growth stimulating agent for the treatment of osteoporosis.

Under the terms of the agreement, Merck gains worldwide rights, except for Japan, to develop and market JTT-305, the companies said.

Japan Tobacco would receive an upfront payment and be eligible to receive additional cash payments on achievement of certain milestones associated with the development and approval of a drug candidate covered by the agreement.

The Japanese-company would also be eligible for undisclosed royalties from sales of any drug candidates that receive approval.

JTT-305 is currently in phase II clinical trials in Japan for its effect on increasing bone density and is in phase I clinical trials outside Japan.

Osteoporosis affects more than 75 million people in the U.S., Europe, South America and Japan

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