How Avoidable are Hospital Readmissions for Heart Failure?

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I knew an elderly man who suffered from heart failure. Every few years, he would get to the point where he couldn’t walk very far, his feet swelled, and he had repeated hospitalizations to get stabilized and get his medication in line. Then, the hospitalizations would stop. He managed reasonably well for some years until he was near the end of his life, when he had lung complications. It wasn’t clear what came first: the lung compromise or the heart failure. He declined rapidly. A friend’s mother has had heart failure for years. She recently started oxygen and is in a hospice program. She hasn’t been in the hospital at all within the past year, and considering everything, she is doing quite well. Yet other older Americans find themselves on a rollercoaster: going in and out of hospitals and not quite understanding their medication regimen, limitations on diet, and the benefits of exercise.

The Centers for Medicare and Medicaid (CMS) has been pushing hard to reduce “potentially unnecessary” and high-cost hospital readmissions for heart failure. More than any other condition, heart failure is the leading cause for readmission. It turns out that, on average, about 1 in 5 people with heart failure will be readmitted within 30 days. A Medicare Payment Advisory Committee survey revealed that Medicare readmissions for all causes total $17 billion.

One target that has been talked about is bringing the heart failure readmission rate down to 1 in 10.

CMS has hospitals scrambling to get these numbers down and nurse-led programs are working to assure better preparation for discharge and self management. The threat of Medicare penalties is looming. Potentially avoidable readmissions for heart attacks, pneumonia, and infections are also under scrutiny.

Hospital Data Viewable on the Web

Some health policymakers consider data on hospital outcomes and patient satisfaction as a potential driver for change.  Already, journalists have picked up the ball, reporting hospitals with higher than average hospital readmissions for heart failure, pneumonia, and infections, and data-hungry public can examine the data now available at the Centers for Medicaid and Medicaid Services MedicareHospitalCompare. Many people think that the public will vote with their feet and take their health care elsewhere if they see high readmission rates or death rates out of whack at their hospitals. It is certainly a consideration, but I wonder whether people in search of care for a chronic condition might pay more attention to outcomes by physicians in their area, if they can find them anywhere. They might pick their doctor, regardless of hospital affiliation.

MedicareHospitalCompare

I spent some time with MedicareHospitalCompare  yesterday, looking at hospitals in my own community. I wish that CMS had a quick-start tutorial on how to use it. I think only data-oriented patients will go through the steps to see how hospitals do in their area. There are limitations with the dataset. You can only compare three hospitals at a time. Some hospitals have data footnoted as problematic, meaning that you don’t know whether to trust it at all. Also, I saw one hospital listed that combined two independent sites that really don’t talk to each other. I flagged one hospital out of six that had a higher than average heart failure readmission rate. I wondered about that and may consider looking for doctors not affiliated with that particular hospital.

Heart Failure Self Management

Policymakers hope that patients with heart failure can be educated to better self-manage their disease. It is certainly an admirable goal. Indeed, around the country, panoply of interventions are being tried, including transitional care, hospital-to-home programs, and cognitive training on medication and weight management. Numerous other strategies are being evaluated, including remote monitoring and telephone consultation. Nurses are doing yeoman work to smooth out the care and their efforts should be applauded. I’ll discuss some of this work in a subsequent post in the next week.

I’d like to hear from readers on what you think would help patients and caregivers. Do you or has someone close to you suffered from heart failure? How are they managing? What has helped them? Is there information that you would like to see made available that would help you pick a doctor or facility that provides high-quality care? Have you participated in any programs that have helped you or your family manage heart failure and stay out of the hospital?

NEXT: SOME OF THE RESEARCH ON LEARNING TO MANAGE HEART FAILURE AND RECOMMENDED BOOKS AND WEBSITES.

Underused, Shingles Vaccine Beset with Problems

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Shingles on the waist, above the eye, and forehead, CDC.

If you talk with people who have had shingles, many will tell you that it took a terrible toll on them and that they wish that they could forget about the entire experience. Some can’t. “Freddy” had shingles three years ago, when he was 61. A decorated Vietnam veteran, he told me that nothing prepared him for the incredible pain, headaches, fever, nausea, and numbness that he had from shingles. Freddy had a painful rash on his left side and fluid filled blisters. His entire left side was affected and he says that he still has numbness. He went to work, but was miserable, and immediately went to bed when he got home. His doctor told him that his symptoms were “classic” signs and symptoms.

In 2006, the shingles vaccine was approved and recommended for people age 60 whose immune system was good. However, the uptake for the vaccine is just 10 percent. If this was the case with uptake of childhood vaccines, people would be in an uproar.

Shingles is caused by the same virus that causes chicken pox, the varicella- or herpes-zoster virus. Once you have chicken pox, the virus remains in your body in a dormant state for the rest of your life. The risk for shingles rises with age.

  • The Shingles Prevention Study found that the vaccine reduced the odds of getting shingles and postherpetic neuralgia (pain along a nerve three months after symptoms begin) by 51 percent;
  • The shingles vaccine is covered under Medicare Part D; however copays vary widely, depending on your plan;
  • About one in three individuals will get shingles in their lifetime;
  • Those individuals who get vaccinated and get shingles will have a less severe case, have decreased likelihood of loss of work, and lower treatment costs;
  • In one study, African Americans got vaccinated less and the risk for shingles was lower; however, researchers maintain that the burden is still considerable and urge all groups to get the vaccine;
  • Because the vaccine was only licensed recently, the duration of its effectiveness remains unclear and is under study.
  • The Advisory Committee for Immunization Practices recommends that people age 60 and over get the vaccine. However, most people don’t know about it, doctors don’t recommend it, and pharmacies often don’t carry it because of storage issues. It is also one of the costliest vaccines available: costing as much as 20 times what the flu vaccine costs, and 4 times as much as the pneumonia vaccine.

Freddy says that he would have definitely gotten the vaccine, but he knew nothing about it. That says something: Freddy works as an analyst for a health agency in the mid-Atlantic.

“This vaccine is a perfect storm,” says Rafael Harpaz, MD, MPH, epidemiologist with the Centers for Disease Control and Prevention, Immunization Services, National Center for Immunization and Respiratory Diseases, Atlanta GA. “It is one of the most expensive vaccines, there are big supply shortages, the manufacturer [Merck] does not promote it, and doctors don’t tell patients about it because it is difficult to get. Added to that are reimbursement issues: it may be unaffordable or require cumbersome paperwork for people to get their money back.”

In New York, one patient told me that she went to several chain drugstores: all told her that they never carry it and her doctor had no idea where to find the vaccine. Finally, a pharmacist at an independent pharmacy told her that the vaccine was on order and that they would have it in four months. That was not all. She’d get a prescription from her doctor, have to pick up the vaccine dose, and have the doctor give her the shot. The pharmacy warned her to check with her health plan on the cost so that she would be sure that she wanted it. She gave up.

Harpaz pointed out that adult vaccines are “an extremely tough sell.” It took decades to get the pneumonia vaccine up front and it took doctors demonstrating that preventing pneumonia was cost effective and pushing it aggressively as a way to stop unnecessary hospitalizations. The pneumonia vaccine is part of Medicare Part B.

Shingles vaccines may not be promoted very much unless more data comes out that demonstrates adverse effects on employee work performance (days out of work, in pain, and discomfort) or high treatment costs linked for people who don’t get vaccinated.

The shingles vaccine is covered under Medicare Part D, but that doesn’t mean it is affordable. Out of pocket expenses for the vaccine are all over the map, very much dependent on who negotiates what contracts with whom.  The Government Accounting Office is exploring ways to make these vaccines more accessible and simplifying payment and reimbursement.

Testosterone Replacement Trials Proceed Slowly

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(part 2 of 2 posts)

Alerting men to screening and treatment for low testosterone may get them in to their doctors faster, but they may be astounded to learn that the science in the field is wanting. The National Institute of Aging only enrolled its first patient in a testosterone replacement trial a little over a year ago, according to Peter Snyder, MD, principal investigator of the trial, and endocrinologist at the University of Pennsylvania, Philadelphia.”You can’t make any conclusions about whether it does any good,” said Snyder, who added that in 2003, an Institute of Medicine Panel urged systematic study in older men and recommended against “widespread, generalized use to prevent possible age-related diseases or for enhancing strength or mood in otherwise healthy older men.”

On the day that the report was released, a New York Times editorial titled “The Testosterone Gamble” opened with this question: “Can American men be rushing into the same reckless use of hormones that brought grief and anxiety to so many unsuspecting women?”

Although proponents of testosterone liken testosterone levels declining in a similar fashion to female menopause and refer to “male menopause” or “andropause,” the IOM Committee concluded that there is “scant evidence” for a shutdown like there is among women. In fact, the Committee concluded that supplements “are only appropriate for indications approved by the FDA (the primary indication is hypogonadism in men who make little or no testosterone.)”

The Committee is not alone in this assessment: many physicians told me that they worry that men will use testosterone replacement therapy before studies of effectiveness, benefits, and any problems are known.

Research Priorities

The wheels of science proceed slowly, perhaps too slowly for those who want to try the latest drug. Without rigorous study, there could be harm. In fact, some research has raised concerns about testosterone accelerating prostate cancer and an enlarged prostate (BPH); one  study was halted because of heart effects.

The IOM Committee pressed for studies that would show whether testosterone is an effective treatment in men with low testosterone levels. Unless a clear benefit is demonstrated, the Committee urged not proceeding to studies of long-term risks.

A top priority is to test testosterone replacement among men age 65 and older whose testosterone levels are below the physiologic levels of young adults. These would be randomized, short-term, placebo-controlled randomized trials. Outcomes should be measured in four areas, weakness/frailty/disability; sexual dysfunction; cognitive dysfunction; and well-being/quality of life. If clinically significant benefit is demonstrated in the early trials, long-term studies should follow,according to the Committee. Safety should be assured in all the trials. Further study of age-related changes in testosterone levels should also be done.

The Testosterone Trial

A coordinated set of six trials is being done at 12 sites around the country, under the direction of the National Institute of Aging, according to Snyder. “We are selecting men age 65 and over with unequivocally low testosterone, 275 ngs on two separate early mornings because these are the men we would anticipate might get the most benefit,” said Snyder. Overall, 80 percent of men have values over 275 at 2 separate times.

Testing testosterone replacement in men age 65 and over is in contrast to the advertising, which focuses on men age 45 and over. “We have strict entry criteria so that men have a very low risk for prostate cancer and at least one of the following conditions: anemia, decreased physical function, low vitality, impaired cognition, or reduced sexual function,” Snyder added. Men in the study either get a testosterone gel (AndroGel/Abbott) or placebo gel to be applied to the torso, abdomen, or upper arms. The testosterone is given first as a loading dose and then adjusted so that the gel brings testosterone into the normal range.

“Of every 100 men who call into our sites, one ends up satisfying enrollment criteria and gets enrolled.” In contrast,  advertising suggests that as many as 38 percent of men age 45 and over have low testosterone and may benefit from treatment.

Caveat Emptor: Direct-to-Consumer (DTC) Ads for Testosterone Replacement Therapy Soar

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Sebastian Botero in the 2005 Tour de France. By J.P. Partland.

“Ted,” a 50-year-old bicycle racer from Philadelphia, saw his primary care doctor for the last time several months ago– when he was advised to start testosterone replacement therapy. “Your labs are excellent,” said Ted’s doctor. “I’d like to frame them.” The lab values included a normal range testosterone level. Ted was there for a regular check-up and he had no particular complaints, except that he was struggling through the after-effects of a motorcycle accident.

Ted’s doctor told him that even though his testosterone level was normal, with testosterone replacement, Ted might be able to build more muscle mass and go all night. It was not as if Ted indicated he was having any trouble on either of those fronts.

“Nah, that’s okay. I don’t think I need it.” Until this episode, Ted had no real complaints about his doctor and found him pretty knowledgeable. Yet the only pamphlets that Ted saw in his doctor’s office were about testosterone. Ted suspects that his doctor, a solo practitioner, may be trying to hit a volume target:  if his doctor prescribes a certain amount of testosterone replacement therapy, he may get rewarded financially by pharma in what Ted calls a “payola” type arrangement.

While the FDA has cracked down on some promotional activities, it’s still probable that doctors are rewarded for just talking up a product. The placards around the office can open a discussion that might never happen otherwise.

Ted became disgusted when he watched the front office staff ask his doctor what code to put testosterone replacement therapy under for an elderly man seen right before him. “My reaction was ‘the bucket must be pretty big if both of us are candidates for hormone replacement therapy’.”

Ad campaigns on television, newspapers, and the internet urging men age 45 and over to get screened for low testosterone and consider long-term testosterone replacement therapy (TRT) are everywhere. It is hardly surprising: hormone replacement therapy (HRT) for women was a blockbuster drug category long before randomized controlled trials went forward. It was not until the Women’s Health Initiative was stopped early because it showed a link between HRT and both cardiovascular disease and breast cancer that this trend reversed itself. The hypothesis that HRT might help avert dementia did not pan out. That marketing is far from over; journal supplements and continuing medical education programs are devoted to highlighting the limitations  of the  Women’s Health Initiative (for example, claiming that the women were not representative) and maximizing any studies suggesting that even a little hormone replacement therapy given with caution is not so bad after all. Now, as pharmaceutical companies take their turn with men, the marketing is proceeding ahead of rigorous scientific study.

Ads Tackle Aging, Low Libido,  and Low Energy

The ads use macho imagery: cars, computers, and racing prominently. Men look moderately overweight in many ads. Some of the information on testosterone replacement on the web targets men with high cholesterol, diabetes, COPD, and asthma, suggesting that testosterone replacement therapy could reverse low libido, a bummed mood, and low energy in men age 45 and over. The catch-phrase “is it low T” appears in several Abbott ads. Abbott makes the testosterone gel AndroGel and Auxilium the testosterone gel Testim. So far, these are the two products in the US market; more are in the pipeline.

Public opinion on these ad campaigns runs the gamut of people who view it as potentially harmful disease-mongering and medicalization of aging to the point of view that testosterone could confer positive anti-aging benefits.

In June, an event was held in New York City’s Times Square, on what is known as Military Island (a military recruiting station has been there for many years), asserting that men care more about cars than they do about their health.The event featured a young race car driver, a race car, and old vintage cars. Now on the Internet, the ad plainly says it is from Abbott. The Times Square event may have been unbranded. It states that the race car driver had his testosterone checked, that it was fine, and he was relieved. if you maintain a high testosterone, you can still drive fast cars and perform like you did 20 to 40 years ago. (Too bad that the event coincided with the Anthony Weiner twitter fiasco –-hardly the optimal time for a big splash for testosterone therapy.)

One television ad shows a robust man slamming a laptop shut, walking across the screen, with the message: “Stop living life in the shadows.” An ad in the Boston Globe ran a few months back showing a healthy looking man in his forties, reading: “Has he lost that loving feeling? He may have low testosterone (lowT).” Frequently men are shown with their female partners who want the guys upstairs in the sack. The men look distracted and disinterested in sex.

In May,  Pharmaceutical Executive gave Heartbeat and Auxilium Pharmaceuticals (Testim) top billing for “rich media ads that helped dispel common misunderstandings of low testosterone symptoms and increase awareness of the condition and its treatment, while keeping a sense of humor about the potentially sensitive medical issue. The unbranded ads were accompanied by the www.lowtfacts.com website and directed users to additional information on symptoms and treatment.

Some low testosterone awareness ads on the Internet that I viewed in May or June had links to the American Diabetes Association (ADA), implying that ADA must espouse the point of view that diabetes is associated with low libido, low energy, and low testosterone; hence, screening for low testosterone in men with diabetes is sensible and safe.  However, such links came up empty—just bringing you to the generic ADA website. This link has since been removed, perhaps because the implication that ADA has guidelines on testosterone screening for men with diabetes is indeed a stretch.

Around the world,  the United States and New Zealand are the  only countries that permit DTC drug marketing, according to Barbara Mintzes, PhD, assistant professor of anesthesiology, pharmacology and therapeutics initiative, University of British Columbia, Vancouver, Canada. If you turn on television during prime time in the US, you are bound to see ads for a multitude of drugs, so much so that it is daunting. In much of the world, DTC drug marketing is illegal. Although DTC drug marketing has been illegal in Canada, the law is not enforced in Canada, Mintzes explains. “This is in part because of the large influence of US media (nearly all Canadians can see US television), and partially because of specific steps that the Canadian government has taken to re-interpret existing laws in a more permissive way,” says Mintzes. Part of this involves the definition of ‘information’ versus ‘advertising,’ another part branded ‘reminder’ ads with no health claims,” said Mintzes. “In both cases Health Canada (federal regulator) has put out advertising policy briefing papers explaining the way the law is being interpreted, and advising industry of what would and would not be considered legal,”stated Mintzes in an email. “It’s a stretch in both cases to connect what’s in those policy papers with the actual words in the law or how it was interpreted previously.”

Canada has a self-regulatory Pharmaceutical Advertising Advisory Board, which can provide opinions on direct-to-consumer ads, and report back to Health Canada. Barbara Mintzes, University of British Columbia. However, as many as 30 percent of Canadians view American television through cable and satellite.

Testosterone Promotional Marketing Questioned

In June, Mintzes and 23 physicians, researchers, and ethicists around the world, including experts at Harvard, Oxford, in Germany, Australia, lodged a formal written complaint with the Pharmaceutical Advertising Advisory Board regarding an ad campaign by Abbott in the June 6 to July 12 Globe and Mail, accompanied by a promotion to physicians, and a Canadian-based website: www.lowT.ca. The ad had been reviewed by PAAB and its logo appeared on the ad, according to Mintzes. The complaint concerns a Canadian ad. It is still pending.

The letter argues: “Not only is the message in this advertisement in contravention of the Food & Drugs Act, it has serious potential to lead to harm to public health, it provides misleading and inaccurate information that would not withstand any serious test of truth in advertising, and it is likely to lead to unjustified increases in health care costs, the latter by promoting testing of men unlikely to be suffering from hypogonadism [the technical term for having a low testosterone]. By redefining this condition to include signs of normal ageing, Abbott is promoting this product for an unapproved use – normal age-related changes in testosterone levels.”

The letter takes issue with promoting testosterone to treat lack of energy, low sex drive, loss of that loving feeling, and urging men to see their doctors for a testosterone test if they experience these things. The low T website also features a 10-question quiz that suggests complaints such as “falling asleep after dinner” or “deteriorating work performance” may be symptomatic of low testosterone.” The email to doctors suggests that 38 percent of men over age 45 could have low testosterone, which the authors contend is inflated.

Also at issue, the authors write, is targeting this to overweight men and those with diabetes, who may be at risk for heart disease. The authors point to a study in the New England Journal of Medicine of testosterone replacement therapy that was halted early because of excess cardiovascular events. (The letter did not address concerns that testosterone is ill-advised in men with prostate cancer or at elevated risk for it, but that has been a concern raised by many physicians.)

The authors of the letter to Canadian authorities also take issue with the “unbranded”campaign, which disguises that it is really from Abbott; this is not in alignment with the WHO Ethical Criteria for Medicinal Drug Promotion, signed onto by all UN Member states. The US ad campaign by Auxilium was similarly unbranded, as was the Times Square/Military Island event.

Testosterone replacement therapy could gain a foothold in markets around the world through aggressive direct to consumer drug advertising and physician incentive programs. Just like hormone replacement therapy for women, it seems to go be going forward with limited science to back broad use.

Later this week: The Science (or lack thereof) to Back Testosterone Replacement Therapy

 

Looking for a Doctor

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Guest Post by Esther Cohen

Many people I know, of every age and proclivity, are looking for a new doctor. Even if they have one already.

A good doctor’s not easy to find. We have, many of us, moved away from the kindly-ish all knowing childhood variety (mine was my Uncle Jack. A large man. No one even Wife Fayette would question his dictums. Health or otherwise). Today we inhabit another universe, where wellness is used every other sentence and Dr. Oz is on TV every single day with advice, where yoga and meditation are part of the common parlance, and many can pronounce ayurveda. What it means is another story, but still.

I’m on the search myself. Here’s what’s on my criteria list: kind, funny, non-invasive (a newish term). Not too test oriented. Talks and listens. Doesn’t make you wait for hours. Takes my insurance. Calls back in a reasonable time period. Has a receptionist who would not be mistaken for Goebels or Goering.

Last week I tried two different candidates: beautiful Indian woman and an overweight 53 year old Jewish man.

The woman, Dr. R., was in an ugly space. (So was he. Aesthetics are not a requirement, though they’d be nice. ) But Roy, the man who met me at her door, Dr. R’s yoga and breathing instructor, was one of the best looking people of all time. He looked as though he could do a quick headstand and maybe teach me too.

Dr. R. sees her patients in the dark. No lights, really. She believes the dark is meditative. I could see her enough to know she too is beautiful. She said Indians believe (she does, anyway) that from 50 on we’re on the other side. She said I could take four kinds of herbs, and coat my skin daily with sesame oil, to hold off my inevitable drying out. Oddly enough, I bought the herbs. I’m not sure why. Conditioning? She also said I should never eat broccoli for lunch. I never do, but on the Dr. R. visiting day, in mild defiance, I ate a Chinese lunch: broccoli in garlic sauce.

Then I went to Dr. P., for my eyes. Even though he’s an eye doctor, Dr. Ps office looks pretty bad. His walls are a color that isn’t a real color – beige-ish, and his paintings are part of the Day’s Inn school – ubiquitous boat on ubiquitous wave. Dr. P., though, was more or less the ideal. He seems to have maximum eye information, but he didn’t find it necessary to recite all the facts. He answered questions and asked a few. Even his receptionist seemed ok. Before handing me the requisite clipboard with questions (wouldn’t it be great if they asked a question like How Do You Feel?) she said Welcome.

I liked Dr. P. enough to ask the question I’ve asked everyone, more or less. Can you recommend an internist? Someone like you, I said. Forget it, he responded. Doesn’t exist. I guess the search continues.

I met a woman in the elevator today. A stranger. Coming from a visit from a new doctor. Someone she’d never met before. How was it? I asked.
Could have been better, she said.