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