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Chemotalk NewsletterChemotalk Newsletter, Vol. 75: July 1, 2014 Starting with a case of "buyer beware": STUDY: CANCER ADS LONG ON EMOTIONS, SHORT ON FACTS By Janet Colwell Advertisements for cancer centers often appeal to consumers' emotions but rarely provide useful information about the benefits, risks, or costs of treatment, a recent analysis concluded. "We found that cancer therapies were promoted more commonly than supportive or screening services and were often described in vague or general terms," the authors wrote in Annals of Internal Medicine. "Advertisements commonly evoked hope for survival, promoted innovative treatment advances, and used language about fighting CANCER while providing relatively limited information about benefits, risks, costs, or insurance coverage of advertised therapies." In the study, funded by the National Institutes of Health, researchers reviewed 409 magazine and television advertisements placed by 102 cancer centers during 2012 (online ads were excluded). Only 5% of the ads mentioned coverage or costs and none talked about insurance plans. Patient testimonials tended to focus on survival but only a few included disclaimers and none described the typical results of treatment. Most of the ads relied on emotional appeals related to survival or potential for cure, the authors reported. Many used phrases with the word "hope" and described cancer as a fight or battle, while others evoked patients' fears and anxieties about surviving their disease. The authors noted that prominent centers credentialed by the National Cancer Institute were just as likely as other centers to omit information about treatment risks, benefits and alternatives, and were more likely to use emotional appeals related to survival or potential for cure. "The findings suggest that emotional appeals coupled with incomplete information are being widely used to promote services, even among the nation's most prestigious cancer centers," the authors said. Most ads attempted to associate a particular brand with feelings of empathy, warmth, and hope, a strategy that has proven more persuasive with consumers than presenting facts, the authors said. Other studies have shown that highly emotional ads are more effective in changing behavior for cancer screening and smoking cessation than ads based on logic. However, while cancer is an inherently emotional topic, ads that focus exclusively on consumers' hopes and fears may lead patients to seek out unnecessary or unproven treatments and expose them to avoidable risks and increasing costs, the authors noted. They may also interfere with patient-physician communication. "Although efforts to explain patients' false hope have traditionally focused on psychological needs or inadequate communication with physicians, advertising testimonials about potential cure may also play a role," they wrote. "To the extent that such advertisements generate inaccurate expectations of treatment benefit, they may complicate providerpatient discussions about prognosis and appropriate therapeutic options." * * * HEALTH INSURERS ARE PUSHING BACK ON DRUG PRICES Creating Competition Prescription Benefits No Longer Cover Some Costly Medicines By Andrew Pollack In dealing with health plans, drug companies are facing a new imperative -- bargain or be banned. Determined to slow the rapid rise in drug prices, more health plans are refusing to cover certain drugs unless the companies charge less for them. The strategy appears to be getting pharmaceutical makers to compete on price. Some big-selling products, like the respiratory medicine Advair and the diabetes drug Victoza, have suffered precipitous declines in market share because Express Scripts, the biggest pharmacy benefits manager, recently stopped paying for them for many patients. "There's clearly more price competition in the marketplace," Andrew Witty, chief executive of GlaxoSmithKline, said, talking about Advair in a recent company earnings call. Executives of pharmacy benefit management firms say they must do something to cope with rising prices, particularly for soc-called specialty pharmaceuticals, which are used to treat complex diseases like CANCER and MULTIPLE SCLEROSIS. Spending on specialty drugs rose 14.1% last year and by even greater amounts in previous recent years, according to Express Scripts. Most of that increased spending comes not from new drugs or new patients, but from price increases on older drugs that can often exceed 10% year after year. Many other countries control drug prices in some manner, so drug companies have become dependent on increasing prices in the United States to grow. Pharmaceutical companies rarely talk in detail about how they set prices or decide on price increases. They generally say that the price reflects the value of the medicine which in some sense is a measure of what the market will bear, They also say that insurers and government programs like Medicaid typically pay less than list price, though how much is usually kept confidential. If health plans are now winning bigger discounts or rebates, it will not show up in the list prices but will help relieve pressure on insurance premiums. That appears to be happening to some extent, Analysts at Credit Suisse estimate that the collective discounts and rebates for 15 large drug companies amounted to 31.9% of gross United States sales in 2013, up from 30.2% in 2012 and 19.7% in 2007. How much bigger and broader discounting will become remains to be seen. Tim Anderson, pharmaceutical analyst at Sanford C. Bernstein & Company, said he had always been skeptical that pharmacy benefit managers could rein in prices. "Express Scripts and other payers can talk tough whenever they want, but it only turns into reality when they have a drug company that is willing to break rank and play the price card," he said. He said that drug companies, while not colluding, "have all looked at hear other and said, 'None of us needs to compete on price if we just hold the line.'" But Mr. Anderson said that they recent developments with respiratory and diabetes drugs does suggest formularies are being tightened. Formularies are lists of drugs that a health plan will cover. Typically they try to wring discounts from drug companies by offering better placement in the formulary. A less expensive drug will have a lower co-payment to encourage patients to use it. But drug companies now help patients with their co-payments through coupons. That removes the incentive for patients to use the lower-priced drugs and lessens the incentive for drug companies to bargain. In response, some pharmacy benefit managers are dropping some drugs from the formulary, rendering the co-payment cards ineffective. If patients want that drug, they have to pay full price by themselves. CVS Caremark, the second-largest pharmacy benefit manager, started excluding about 30 drugs in 2012 and this year is excluding about 70 from the formulary used by many of its employer clients. Express Scripts this year began excluding 48 drugs or medical products, including Advair and Victoza. Catamaran began offering an optional formulary this month that excludes 54 drugs. With exclusions, bidding to get on the formulary becomes more of a winner-take-all contest. The winning companies gain more market share because rivals are excluded, so "they are willing to give us greater discounts," said Dr. Steven Miller, chief medical officer of Express Scripts. He said the new formulary, which covers more than 25 million people, would save about $700 million this year for clients who adopt it, or about 2 to 3 percent of their spending on drugs. Jonathan C. Roberts, president of the pharmacy benefit management at CVS Caremark, said there was an average combined savings for health plans and patients of $67 for each prescription switched from an exclude drug to a covered drug. The new Express Scripts formulary went into effect or most patients in January, and the effect on prescriptions was swift. Advair sales in the United States plummeted 30% in the first quarter, while sales of AstraZeneca's Symbicort, a rival that remained on the formulary, grew 20%. Novo Nordisk executives said that overall sales growth for this year would be about 2 percentage points lower than they would have been because Express Scripts had excluded both Victoza and Novo's mealtime insulin products. Other pharmacy benefit managers say they use exclusions more sparingly. "We are seeing an increased request for these narrower formularies and excluded drugs," said David Lassen, chief clinical officer at Prime Therapeutics, a pharmacy benefit manager owned by various Blue Cross and Blue Shield plans. But he and some other executives said exclusions could cause disruptions for patients who must switch drugs. They can be used only when there are several equivalent drugs available, lest doctors and patients complain. "You can't just go for the least expensive," said Dr. Brian K. Solow, chief medical officer of OptumRx, which is owned by the UnitedHealthcare Group. "You have to think about what is best for patients." In March, Medicare, under heavy pressure from drug companies, patient groups and Congress, abandoned a proposal to allow Medicare Part D plans to exclude some drugs for depression and schizophrenia. Patients with Gaucher disease protested when UnitedHealthcare recently required virtually all patients to use just one of the three similar and very expensive therapies available for that disease. Patient groups have also expressed conce4n that health plans offered through the new insurance exchanges tend to have more exclusions and other restrictions on drugs than employer-funded plans. Dr. Miller said the excluded drugs represented only a carefully selected 1% of drugs covered by Express Scripts and that the company had little problem switching patients. The battle could escalate. Mr. Roberts said CVS next year would offer an optional formulary with 200 exclusions. Glaxo is now essentially offering to provide drugs affected by formulary restrictions free of charge to keep patients using its products. Novo Nordisk executives said on the company's first-quarter earnings call that the competitors who outbid them for the Express Scripts contract had not really gained much because they were paying higher rebates in exchange for a slightly higher market share. That might discourage companies from competing on price in the future. "I would tend to believe the players will act to expand the segment if they have long-term interest in being in this field," Novo's chief executive, Lars Rebien Sorensen, said. A big test of the strategy could come next year with drugs for hepatitis C. Health plans are worried about their ability to afford Sovaldi, a new drug from Gilead Sciences that costs $84,000 for a typical course of treatment. But AbbVie and Merck are expected to introduce competitive drugs, and the payers hope to pit one manufacturer against another to drive down prices. The AbbVie chief executive, Richard Gonzalez, in response to a question in the company's first-quarter call, suggested his company would compete on the merits of its product, not price. `"We have a product profile that stands up quite nicely in the marketplace, so that's not our strategy going forward," he said. A top Pfizer executive made a similar comment when asked if the company should offer bigger discounts on Xeljanz, a new pill for RHEUMATOID ARTHRITIS that was excluded by Express Scripts. But some executives say they sometimes have no choice but to deal. "We are fighting to make sure that patients continue to have choice," Enrique Conterno, who runs the diabetes business at Eli Lilly, said in his company's call. Nonetheless, he added, "We need to be competitive whenever a payer basically makes the decision that they are going to narrow the formulary." * * * OUTSMARTING BREAST CANCER By Jane E. Brody Over the past few decades, changes in the treatment of breast cancer amount to a revolution in patient care. And its not over yet. There was a time when the standard approach was a radical mastectomy, which involved removal of not just the breast, but all the lymph nodes in the armpit and underlying muscles in the chest wall. This approach has been replaced by less extensive surgery that, through decades of clinical trials, has proved to b3 equally effective at treating patients, as well as safer and less disfiguring. Dr. J. Dirk Iglehart, director of the Susan F. Smith Center for Women's Cancers at Dana-Farber Cancer Institute in Boston, estimated that he now performs a tenth of the number of mastectomies than when he entered the field I the 1970s. Currently, most women with early-stage breast cancer have a lumpectomy; only the tumor and a small margin of surrounding normal tissue are removed, along with a few lymph nodes. Patients then receive localized radiation therapy and often drug therapy to head off a recurrence. Even though this approach is less aggressive, breast cancer death rates have dropped steadily since 1990, a combined result of earlier diagnosis and medical therapies developed largely through a major national investment in cancer research, according to Dr. Clifford A. Hudis, chief of breast cancer medicine service at Memorial Sloan-Kettering Cancer Center in New York. "Treatment today is getting much more individualized," Dr. Hudis said, Depending on the molecular nature of a woman's tumor; postoperative hormonal or other drug treatments are routinely prescribe to prevent or delay a recurrence of disease. Still, with nearly 40,000 breast cancer deaths annually in this country, more needs to be done. Instead of waiting for cancer to recur in curtain high-risk patients, scientists are now developing techniques to outsmart the cancer cell's aggressive tactics by prompting the patient's immune system to execute a continuous attack that keeps the disease at bay indefinitely. Another nonsurgical approach under study involves destroying the tumor by freezing it with an ice probe but leaving it in place so that the immune system can be trained to attack it, Dr. Hudis said. The patient then would be given an immune stimulant to help overcome the molecular obstacles that had kept the immune system from recognizing the cancer as foreign tissue. When tumors are more advanced at diagnosis, it is already sometimes possible to minimize the extent of surgery without compromising a woman's chances of disease-free survival. "The size of the tumor and presence of positive nodes may not matter as much as we thought," said Dr Deborah M. Axelrod, a surgeon who directs breast cancer programs at the center. "It's not even true that if the cancer is metastatic, it's curtains." Tests are being developed to help doctors predict an individual patient's response to various therapies, Dr. Axelrod said. Patients now are encouraged to become well informed about their disease and possible therapies and to participate in treatment decisions. "There's no right or wrong decision as long as patients are well informed and choose what is best for them," said Dr. Jennifer K. Litton a surgical oncologist at M.D. Anderson Cancer Center in Houston. "The old days of paternalistic medicine are gone." Also gone is the simplistic notion that cancer is a disease of abnormal cell division, said Dr. Larry Norton, deputy physician in chief for breast cancer programs at Memorial Sloan-Kettering. "It's a disease of abnormal relationships between the cancer cell and other cells in its environment." This new perspective "is leading to changes in treatment," he said. For example, current surgery for breast cancer involves removing only a few lymph nodes for testing, which avoids complications like a chronically swollen arm. "We know that in many cases we're leaving behind nodes that contain cancer cells, but it doesn't hurt the patient to leave them there," Dr. Norton said. "Cancer cells require other cells in their vicinity to help them grow," he added. "Understanding how the cells communicate is opening new opportunities to keep cancer cells from forming a tumor." Knowing that the effectiveness of treatment is reduced once breast cancer has metastasized -- that is, spread to other regions of the body -- researchers are now testing creative ways to prevent such recurrences. One, a vaccine called NeuVax, is in the final stage of multinational clinical tests under the direction of Dr. Elizabeth A. Mittendorf, a surgical oncologist at M.D. Anderson. The vaccine is made from a peptide, a small piece of a cancer protein, that is combined with an immune stimulant. Early results suggest that the vaccine can reduce the risk of recurrence by 50% among breast cancer patients those tumors produce low levels of the protein HER2, a marker for more aggressive breast cancer. Without the vaccine, such patients have a 20% chance of a recurrence, Dr. Mittendorf said. Rather than waiting to see if a patient's cancer comes back, doctors given the vaccine at the time of initial treatment, when few if any cancer cells are present, she explained. Changes have already taken place in postoperative radiation for breast cancer that reduce side effects and minimize potential long-term damage to organs under the breast. After surgery to remove the tumor, the breast may be only partly irradiated. Radiation can be focused on the cancerous area using a more intense but shorter course of treatment, Dr. Axelrod said. And while CHEMOTHERAPY is anything but pleasant, measures like anti-nausea medication and massage are now commonly used to minimize patient discomfort. * * * The following piece isn't related specifically to the topic of chemotherapy, but it is relevant. MY LIFE AS A DOG OWNER By Jane E. Brody As I approached four years as a widow, the loneliness of a one-person household began to drag me down. Acquiring a four-legged companion, rather than a two-legged one, appealed to me. And so, in February, I adopted a 5-month-old puppy, a hypoallergic Havanese small enough for me to pick up and carry, even into my ninth decade, when I travel to visit family and friends. While most dog owners I know encouraged my decision, several dogless friends thought I had lost my mind. How, with all my work, travels and cultural events, was I going to manage the care of a dog? No on asked this when I decided to have children. In fact, few people consider in advance how children will fit into their lives. I you want a child badly enough, you make it work. I am now making it work with MAX II (this name is an homage to a dog my family had years ago), and I am besotted. He's smart -- smart enough to know when I really must work and cannot spend time throwing a ball for him. As I write this, he's asleep on the floor at my side, although during a phone interview two weeks ago, he managed to shred every piece of paper he could grab in my study. Yes, he's a lot of work, at least at this age. But like a small child, Ma makes me laugh many times a day. That's not unusual, apparently: In a study of 95 people who kept "laughter logs," those who owned dogs laughed more often than cat owners and people who owned neither. When I speak to Max, he looks at me lovingly and seems to understand what I'm saying. When I open his crate each morning, he greets me with unbounded enthusiasm. Likewise when I return fro a walk or a swim, a day at the office, or an evening at the theater. But perhaps the most interesting (and unpremeditated) benefit has been the scores of people I've met on the street, both with and without dogs, who stop to admire him and talk to me. Max has definitely increased my interpersonal contacts and enhanced my social life. People often thank me for letting them pet my dog. Max, in turn, showers them with affection. Prompted by my son, a fellow dog lover, to explore the health benefits of pet ownership, I dug into the literature, focusing first on what pets can do for older adults, then branching out to people in all age brackets. More American households have dogs than any other type of nonhuman companion. Studies of the health ramifications have strongly suggested that pets, particularly dogs, can foster cardio vascular health, resistance to stress, social connectivity and enhanced longevity. The researcher Erika Friedmann, whose groundbreaking study in 980 showed that, other factors being equal, people with pets were more likely to be alive a year after discharge from a coronary care unit, said studies also have linked pet ownership to lower blood pressure, cholesterol and triglycerides -- even though owners drank more alcohol, ate more meat and weighed more than those without pets. Other studies have found that older people who walk dogs are more likely than those who walk with human companions to engage in regular exercise and physically fit. Controlled studies by Dr. Friedmann, a professor at the University of Maryland School of Nursing, have also demonstrated a lower level of physiological arousal from stress-inducing situations when a friendly animal was present. I can't yet say that Max II has reduced my anxiety. I remain ever alert to his need to head outside and his attempts to chew or tear up anything he can reach. But there is no question that I am thrilled by his antics, endearing personality, unconditional love (even when I yell no) and the many connections he's fostered with both acquaintances and strangers. `As a study published in 2007 in Society & Animals concluded, pets "ameliorate some determinants of metal health such as loneliness." In a survey of 339 residents of Western Australia, the researchers found pet ownership to be associated "with social interactions, favor exchanges, civic engagement, perceptions of neighborhood friendliness and sense of community." Elderly dog owners report "significantly less dissatisfaction with their social, physical and emotional states," according to a 1993 study by veterinary researchers at University of California, Davis. Children, too, can benefit from pet ownership, medically and socially. Rates of asthma and eczema are lower among children with dogs at home from infancy onward. Among boys in particular, who may have few activities that foster nurturing behavior, caring for a pet enhances emotional development and security, according to Gail F. Melson, professor of developmental studies at Perdue University. She found that 5-year-olds who turn to pets for support are rated by parents as less anxious and withdrawn than comparable children who have pets they don't rely on. But before acquiring any pet, and especially a dog, Alan M. Beck, who heads the Center for the Human-Animal Bond at Purdue, urges people to carefully consider the implications. "Look for an animal of an appropriate breed, size and temperament for your household," he said. "Do you have the income, exercise ability and time the pet needs?" In an interview, Dr. Beck suggested speaking to owners with the kind of pet you are considering. If possible, visit a household with one. Better still, he said, try pet-sitting for a few days or fostering an animal for a few weeks to appreciate more fully what pet ownership entails and to determine if you are up to the task. "If you're going to get a dog, you should be prepared to spend time on basic training and socializing the animal," Dr. Beck said. "A properly socialized dog is better behaved and less likely to be aggressive and bite someone." In an interview, Dr. Friedmann noted that "pets are not a panacea" to be treated like a drug taken when you feel unwell. "Living with a companion animal involves responsibilities, the establishment of structured routines for feeding, exercising and nurturing," she said. "The benefits you derive from the animal are linked to these responsibilities." * * * I can relate. See you next month. * * * And if you have any thoughts of how this newsletter could be improved, please email me directly, at Elaine@elainejesmer.com. Elaine Jesmer
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