HPV Vaccine can Prevent Genital Warts in Men

Study results bolster drugmaker’s plan to market shots to boys

The Associated Press
updated 1:28 p.m. ET, Thurs., Nov. 13, 2008

ATLANTA - For the first time, an expensive vaccine aimed at preventing cervical cancer in women has proven successful at preventing a disease in men, according to a study released Thursday by the vaccine’s maker.

The disease is genital warts — sexually transmitted, embarrassing and uncomfortable — but not life-threatening.

Still, the results are expected to bolster a likely bid by the vaccine’s manufacturer, Merck & Co. Inc., to begin marketing the vaccine to boys, experts said. Merck plans to ask the government for that approval later this year.

“This opens the door to a wonderful opportunity to prevent illness,” said Anna Giuliano, a researcher at the H. Lee Moffitt Cancer Center in Tampa, Fla., who worked on the Merck study. The research results were being presented Thursday at a medical conference in Europe.

The focus was Merck’s vaccine, Gardasil, which is given in three doses over six months and is priced at about $375.

The vaccine targets the two types of HPV, or human papillomavirus, believed to be responsible for about 70 percent of cervical cancer cases, and two other types that cause most genital warts. HPV is spread through sex.

In 2006, the U.S. government licensed the vaccine for use in girls and women ages 9 to 26. Males can spread the virus, but the vaccine was not licensed for them because there was no evidence it prevented disease in men.

Though about 40 other countries have approved the vaccine for males, there still is no medical proof Gardasil prevents penile cancer or other HPV-associated cancers in men. There also is no evidence it prevents men from spreading HPV to women.

The new study involved about 4,000 males ages 16 to 26 in nearly 20 countries. Results showed the vaccine was 90 percent effective in preventing genital warts, with only 15 cases of persistent infection in the vaccinated group, compared to 101 cases in a group that was given a fake vaccine.

No serious side effects were reported. The research is continuing, but these results reflect how the men were doing about 30 months after the injections, on average.

The results are “very exciting,” but it’s not clear they will be enough to persuade many American families to get their teenage boys vaccinated, said Dr. Maura Gillison, an HPV researcher at Johns Hopkins University who was not involved in the Merck study.

She noted that only 1 in 4 girls have gotten the vaccine so far, despite compelling medical studies that indicate the shots prevent female cancers.

“When parents are sitting in a room discussing with a pediatrician whether to vaccinate their child against anything, they’d like to know what the potential benefit is. A parent might say, ’I’m not inclined to vaccinate my child to prevent a benign genital wart,”’ she said.

Government officials have been awaiting this interim analysis from Merck. They are eager to see additional information that may come later on the vaccine’s effect on precancerous lesions, said Dr. Lauri Markowitz, an HPV expert at the U.S. Centers for Disease Control and Prevention.

“It’s obviously encouraging data, but the policy makers will be looking at a variety of different issues,” including how cost-effective the shot would be if used in males, said Markowitz, a medical epidemiologist.

HPV causes at least 20,000 cases of cancer in the U.S. each year. Cervical cancer is the most common type, but about a quarter of cancers occur in men, including penile, anal and even head and neck cancers.

© 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
URL: http://www.msnbc.msn.com/id/27697369/

VM2 December: Shared Decision Making: Physicians’ Duties to Patients and Other Physicians

Resident physicians have a duty to patients when they suspect that an attending physician’s treatment decision has risks about which the patient is unaware.

Commentary by Dawn Brezina, MD

Drs. Johnson and Blake were grabbing a quick bite in the hospital cafeteria. Both were second-year residents in internal medicine, but on different teams. Dr. Johnson's team was headed by a hospitalist (Dr. Norwood), while Dr. Blake's team was headed by rotating attending physicians who came through for 2-week, in-house assignments and then went back to their regular academic and clinic responsibilities. For the current, 2-week block, the general internal medicine attending was Dr. White.

Learning Objective: Understand resident physicians’ duty to patients when they suspect that an attending physician’s treatment decision has risks about which the patient is unaware.

In conversation, Dr. Johnson brought up a patient he had been especially concerned about for several days. “Remember the patient I told you about with cirrhosis? Mr. Hanson? His ascites and edema are out of control. We tapped him just 2 days ago and the fluid's already reaccumulating. When we rounded this morning, Dr. Norwood had us order a transjugular intrahepatic portosystemic shunt (TIPS) for him. It's scheduled for tomorrow morning. I sure hope it gives the guy some relief; he's not looking good.”

“Funny you should bring up that case,” his friend said. “Mr. Hanson is one of Dr. White's clinic patients so I asked Dr. White if we had time to stop by Mr. Hanson's room this morning, even though he isn't assigned to our team, because you had mentioned him the other day. We did stop in and, when Dr. White saw the TIPS order, he launched into quite a lecture.”
“Why? What about?” Dr. Johnson asked.

“Oh, Dr. White said that he's sure it's a good decision from the hospital's point of view; the hospital can discharge Mr. Hanson and free up a bed. But then Mr. Hanson goes home, starts getting confused and not taking his meds, and shows up in the clinic. Poor Mr. Hanson has just traded his ascites for encephalopathy.”

“That sounds like a reasonable argument against doing it. What do you think?” Dr. Johnson asked.

“I'm not sure.” Dr. Blake said. “I'd like to hear them discuss it, to be truthful.”
“Right,” said Dr. Johnson. “Like you want to be the one to go to Dr. Norwood and suggest that this is a great ‘teaching moment' and that he and Dr. White should examine this clinical decision together for our edification.”


Commentary

This is an interesting scenario that highlights questions in ethical decision making in caring for hospitalized patients. Central to this issue, particularly for patients with very serious illnesses, are the potential risks and benefits of the specific intervention. Dr. Johnson seemed surprised to learn of the significant risk of post-TIPS portosystemic encephalopathy. And Drs. Norwood and Johnson have ordered this procedure without discussing the risk to the patient.

Until about 1990, an attending physician's active participation on the general medicine service was limited, and the service was essentially run by house staff. The attending physician was available, reviewed all charts, and helped when asked. Nevertheless, he or she was able to bill for all interventions the patients received. In that model, not all patients routinely benefited from the more-experienced physician's knowledge. On the other hand, senior residents and interns felt a sense of ownership and responsibility for their patients. The new legislation made it illegal for the attending physician to bill for patient care unless he or she could document having directed the care. The attending physician's role in patient care decisions increased as a result of the new reimbursement legislation, and house staff autonomy eroded, sometimes causing residents to feel less responsible for patient-management decisions.

In our case scenario, the teaching service team appears to have a hands-on attending physician, Dr. Norwood, who ordered the TIPS intervention without discussion. One of Dr. Norwood's residents, Dr. Johnson, discovered information at lunch with his friend that could greatly impact the clinical course for the patient—and in time to do something about it—which creates an obligation for him to act on the information. TIPS may be the correct course, but if a reasonable doubt exists, the decision should be examined.

The patient needs to have some voice in this decision also. Diuretic-refractory ascites is one indication for TIPS, but the patient must be aware of the subsequent risk for encephalopathy. The most sacred premise in medical decision making is recommending what is best for the patient—and that may not be the same for every patient. Is the patient so miserable he welcomes the relief offered by the procedure, or is he deathly afraid of encephalopathy?
Presumably, it fell to Dr. Johnson to explain the TIPS decision to Mr. Hanson, but we are not told that he did.

Another aspect of hospital care is communication with the patient's primary doctor. Unless a procedure is emergently needed, consultation with the primary care physician is always an asset to decision making. Drs. Norwood and Johnson should have routinely contacted the physician Mr. Hanson saw in the clinic—Dr. White—for recommendations at the time the decision was being considered. This is not only courtesy; it is essential for follow-up management. Dr. White was correct—the patient may very well come to the clinic with encephalopathy in 3 weeks.

Dr. White incidentally discovered that Mr. Hanson was scheduled for a procedure that he believed would adversely affect his life—but it appears he only mentioned it to the house staff team. Dr. White even suggested that the decision was made from “the hospital's point of view” in order to “free up a bed,” and presumably he was still content to walk away and wait for the patient to show up at the clinic, “having traded his ascites for encephalopathy.” Unless Dr. White intervened after his “lecture” to the residents, his action is unconscionable. Having seen Mr. Hanson in the clinic, Dr. White had an obligation to intervene on Mr. Hanson's behalf, if he truly believed the plan of care was not in his patient's best interest.

Medicine is the process of diagnosis combined with therapeutic decision making. Routine illnesses, such as community-acquired pneumonia, are essentially treated by a decision tree and do not require detailed discussion. Likewise, when a patient is being evaluated, no extensive discussion, other than explaining what the anticipated work-up will entail, is needed prior to low-risk diagnostic procedures, such as ultrasound and lab work. On the other hand, therapeutic interventions that carry risks for complications or compromised lifestyle require patient understanding and agreement. No one would start chemotherapy or radiation therapy without extensively explaining to the patient the risks and benefits anticipated from this therapeutic option. Clearly, the TIPS treatment option was not discussed with Mr. Hanson before it was ordered.

Anyone's best interest can only be assessed after considering his or her fears and desires. Some people are bold risk takers and willing to try aggressive management with high risks. Others would rather live with the illness than undergo painful procedures. Patients should be given information in a way they can understand, followed by the physician's recommendations. With that data, the patient may express his or her personal concerns and desires for the anticipated course of treatment.

In this scenario, it appears that Mr. Hanson was not included in the risk/benefit analysis of the planned TIPS procedure. Actually, not even the house staff were included in the discussion. There are several types of shunts used in the TIPS procedure. The larger the shunt, the more likely the patient is to develop encephalopathy. In some cases, the shunt can later be reversed or, in some institutions, it can subsequently be mechanically reduced—these options might greatly influence the patient's decision to proceed or not.

Other concerns include the reliability of the patient. If Mr. Hanson is unable to comply with the post-procedure medication regimen, as Dr. White suggested, the risk of encephalopathy increases. This is another important reason for including the primary care physician in the decision analysis—he or she may have better insights concerning the likelihood that the patient will successfully manage follow-up care.

The hospital's interest plays a role in patient care decisions but is not the primary concern. Patient length of stay is important, especially in the present environment of declining hospital revenues, and hospitalists are encouraged to move patients to the outpatient setting as soon as possible. That said, if this were, in fact, the motive to proceed with the TIPS rather than inhospital diuresis, that would be a great disservice to Mr. Hanson—who is trusting that the decisions will be made in his best interest—and could be deemed unethical.

Dr. Johnson already knows the correct ethical course. He should go to Dr. Norwood—with data in hand on TIPS procedures—and suggest that this is a great “teaching moment.” Open discussion between Drs. Norwood and White would undoubtedly prove helpful to the house staff involved. Perhaps even more importantly, the discussion would be a great benefit to Drs. Norwood and White.

Dawn Brezina, MD, is a member of the Duke University clinical faculty and Hospitalist Program at Durham Regional Hospital, Duke University Health System in North Carolina. She received a medical degree from the University of Miami Miller Medical School and is ABIM board certified in internal medicine. Her areas of interest include pre-operative and peri-operative management and pre-operative clinic.


Related in VM
Indications for Use of TIPS in Treating Portal Hypertension, December 2008

Breast Changes Tell Whether Treatment Works: Study

Sat Dec 13, 2008 8:04am EST
By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) - It may be possible to predict which breast cancer patients will be helped by tamoxifen based on changes in so-called breast density, researchers reported on Saturday.

Women with dense breasts -- a term meaning they have more non-fatty tissue -- are known to have a higher risk of breast cancer and the study suggests that lowering density using tamoxifen also lowers the chances tumors will come back.

Women whose breasts became noticeably less dense after a year or so of taking tamoxifen had a 63 percent reduced risk of breast cancer, the team of British researchers told a breast cancer meeting in San Antonio, Texas.

"It is important to find a way to predict who will respond to tamoxifen, and changes in breast density may constitute an early indicator of benefit," said Jack Cuzick of the Wolfson Institute of Preventive Medicine in London.

He said about 10 percent of women have dense breasts. Such breasts are harder to read on mammograms but there is evidence the tissue in their breasts may be more cancer-prone.
"Women with dense breasts are typically at four to five times the risk of developing breast cancer than women without dense breasts," Cuzick told reporters in a telephone briefing.
Cuzick's team had conducted one of many studies that showed high-risk women who took tamoxifen were at least 40 percent less likely to either develop breast cancer, or to have it come back.

They went back and looked at all the mammograms of the more than 1,000 women who took part in the study.

If a woman's breast density did not change during the treatment, she was much more likely to develop cancer despite taking tamoxifen, Cuzick told the meeting.

TWO-THIRDS REDUCTION
"Women who lost 10 percent or more in breast density -- 40 percent of the women getting tamoxifen -- had a 63 percent, almost a two-thirds, reduction in all breast cancer," he told the briefing.

Cuzick stressed the study only looked at tamoxifen and not at other treatments, such as the newer drugs known as aromatase inhibitors. But he said it validated the idea of using breast density as a way of telling whether a treatment is working, whether tamoxifen or something else.

"If a woman doesn't show breast density dropping within a year or so, you might want to consider other therapy," Cuzick said.

In another report, a team at the Mayo Clinic in Rochester, Minnesota said they found some clues as to why dense breast tissue is more likely to develop tumors.

Dense breast tissue contains more cells believed to give rise to breast cancer, Dr. Karthik Ghosh told the meeting.

Dr. Celine Vachon and colleagues found that dense breast tissue has more aromatase enzyme than non-dense tissue. This is significant because aromatase helps convert hormones into estrogen, which can fuel breast cancer development.

"If aromatase is differentially expressed in dense and non-dense breast tissue, this could provide one mechanism by which density may increase breast cancer risk," Vachon said in a statement.

No butts about it — fecal transplants work for some

By JoNel Aleccia

Before she got so sick with a Clostridium difficile infection, Vicki Doriott would have been as disgusted as anyone at the idea of a fecal transplant.

Infuse her gut with someone else’s stool? Through a tube in her nose? No, thanks.

But in June 2004, Doriott was actually relieved to show up at a Duluth, Minn., clinic, where doctors sent samples of her husband's excrement sliding into her stomach – and apparently cured the infection that threatened to ruin her life. 

“When those toxins are in your body, you kind of feel like you’re close to death,” said Doriott, 52, an accountant from Eau Claire, Wis., who spent nearly six months battling recurrent bouts of the nasty intestinal bug known as C. diff.  “Nothing else I tried worked.”

Doriott is among a growing number of people who’ve undergone the seemingly gross procedure in a  last ditch effort to restore normal bowel function after severe, recurrent C. diff infection. The little-known technique gained new fame last month when an episode of “Grey’s Anatomy” highlighted the quirky cure that helps 85 percent of those willing to try it.

By coincidence, the specialist who performs most of the fecal transplants in the nation, Dr. Tim Rubin of theDuluth Clinic Digestive Health Center, happened to be channel-surfing at the time. Rubin gave the TV docs a thumbs up in handling the procedure.

“They did very well,” said Rubin, a gastroenterologist.

About the only thing the docs at Seattle Grace got wrong was the method of the preparing the fresh, donated stool that repopulates the gut of C. diff infection sufferers with healthy bacteria. 

“They showed a doctor stirring up a bowl of brown stuff at the bedside and that’s not how it’s done,” said Rubin.

And he should know. As far as Rubin can tell, he and his senior colleagues are the only crew in the country who regularly perform the rare, but growing procedure, variously known as fecal transplant, stool transplant and fecal infusion. 

Since 2002, they’ve performed 64 poop transfers on patients with two or more incurable bouts of C. diff. It’s a technique first documented in the early 1990s by researchers in Norway investigating the best way to treat C. diff infection, which typically occurs when the normal flora in the gut is disturbed, most often by antibiotic use.

Rates of C. diff are skyrocketing in the U.S., where a recent study found 13 of every 1,000 patients in the nation’s hospitals are infected or colonized with the germ.

The antibiotics destroy good bacteria in the colon, allowing the C. diff to flourish. The bug can cause illnesses ranging from severe diarrhea and colitis to blood infection, and in worst cases, death. Most patients with C. diff can control it with powerful antibiotics such as metronidazole, sold as Flagyl, or vancomycin. But in about 20 percent of the cases, even those strong drugs don’t work.

That was the case for Doriott, who figures C. diff spores in her gut were activated when she had two rounds of antibiotics for a sinus infection and dental work within six months. 

“At its worst, I’d have diarrhea every 15 minutes,” recalled Doriott. “I’d be going for two or three days. I’d have a 103-degree fever. I couldn’t make it two steps from the couch.”

After months of exhaustion and illness, Doriott became desperate enough to consider the fecal transplants she’d heard about through research. She contacted Rubin in Duluth and made an appointment for the hour-long office visit.

Typically, patients ask a close household member, usually a spouse, to produce a sample of stool, which is tested for disease and infection. In Doriott's case, her husband, Jerry, 50, a civil engineer, was on tap.

On the day of the transplant, donors provide the feces, which is blended and filtered. A tube is fed through the patient’s nose into the stomach and several teaspoons of the sample are injected through it.

“I refused to look at it,” said Doriott. “All I felt was a coolness. It didn’t smell.”

Doriott said she felt better immediately and hasn’t suffered a C. diff relapse since the treatment. Other patients take a few weeks or even months to recover, Rubin said.

A 2003 case study of 18 patients who received fecal transplants found that two patients who were very ill died shortly after transplant. But of the remaining 16 patients, only one developed C. diff again, according to the study published in the Journal of Clinical Infectious Diseases.

Still, fecal transplant has yet to become a widespread treatment, Rubin said.

“You’re going to go to some places and they’re going to, no pun intended, pooh-pooh it,” he said.

Some scientists worry about controlling infection in donor stools and about finding a good way to handle and process the material, said Jennie Mayfield, a clinical epidemiologist at Barnes-Jewish Hospital at the Washington University School of Medicine in St. Louis, Mo.
And some doctors and patients are still squeamish about the procedure.

“It think it’s the kind of thing in the U.S. where people are talking about it, but people don’t want to go there yet,” Mayfield said. “They’d have to give me Valium.”

But Rubin and Doriott agreed that by the time patients are ill enough with C. diff to consider fecal transplants, neither the ick effect nor the potential for bad puns is a factor.

Dorriott, meantime, has managed to put the event behind her. “My husband doesn’t joke too much,” she said, “because he saw how sick I was.”

Obama taps former Senate chief Daschle to head HHS

The nominee has proposed creating a federal health board to increase the transparency and value of health care spending.

By Doug Trapp, AMNews staff. Dec. 8, 2008.


Washington -- Praise for the nomination of former Senate Majority Leader Tom Daschle to be the next Dept. of Health and Human Services Secretary began even before President-elect Barack Obama's transition team confirmed the pick had been made.

At press time, Obama had not confirmed that Daschle would be his choice to head HHS. However, Democratic sources, speaking on condition of anonymity because they were not authorized to make announcements for the next administration, indicated that the South Dakota Democrat had accepted the president-elect's request to be the nominee. Also, Obama on Nov. 19 named Daschle to head the transition team's working group on health care. This means Daschle will be the incoming administration's point person on health care policy and legislative priorities.

The initial reaction to Daschle as the HHS nominee was largely positive. "Daschle would be an effective leader of the nation's health department," said American Medical Association Board of Trustees Chair Joseph M. Heyman, MD.

The nomination still requires Senate approval. Sen. Max Baucus (D, Mont.), chair of the Senate Finance Committee, said Daschle would be a great pick for HHS chief. "Daschle knows health care, he knows the Congress and the rhythms of the Senate in particular."

The Republican National Committee criticized Obama for using what they consider a loophole in his pledge not to appoint lobbyists to key positions in his administration. Daschle is not a registered lobbyist, but since 2005 he has been a special policy adviser on health care issues for the law firm Alston and Bird, which does lobby Congress.

Daschle served in the House from 1979 to 1987; the Senate from 1987 to 2005. He was Senate majority leader for part of 2001 and 2002 and continued to lead the party in the upper chamber until he lost his re-election bid in 2004. Since 2005 he also has been a fellow at the Center for American Progress, a liberal policy organization.

In 2007, Daschle joined former Senate majority leaders Howard Baker (R, Tenn.), Bob Dole (R, Kan.) and George Mitchell (D, Maine) to form the Bipartisan Policy Center. The organization is dedicated to finding bipartisan solutions on difficult policy issues, such as health care, and its recommendations on health reform are due by the end of this year.

Daschle also wrote a recent book on health system reform. Critical: What We Can Do About the Health-Care Crisis calls for more government analysis and regulation of health care spending. He proposes creating a federal health board that would set standards for the health care industry in much the way the Federal Reserve Board does for the financial industry.

Daschle writes that the government should pay more for high-quality care that leads to good outcomes and stop paying for unnecessary care. To this end, for example, the health board could sponsor comparative effectiveness research on medical treatments to help set evidence-based standards for federal health programs.

VM1 December: The Hospital Care Revolution

Introduction to the December issue of Virtual Mentor on the theme of hospitalists and patient care.

There's been a quiet revolution over the past dozen years in the way patients are cared for in hospitals. Its outcome is the growing presence of the hospitalist—a physician whose focused area of practice is caring for patients while they are hospitalized. Hospitalist management of inpatient care means fewer visits to the hospital by the patient's office-based, primary care physician. In some regions and hospital systems, so-called “outpatient” physicians transfer care of their patients to the new inpatient specialists the minute the patient becomes hospitalized and resume care when the patient is discharged.

The several efficiency- and patient safety-related reasons for the revolution are well documented in this month's Virtual Mentor. (No one mentions that central casting challenges and plot stability demands drove daytime drama to invent the hospitalist quite some time ago. The de facto hospitalist appeared on General Hospital before he showed up at Mass. General.)

The questions of greatest interest to this month's contributors concern the effect of the new model of hospital medicine on patients. Have patients lost something critical to their well-being now that their own primary care physicians do not stop in to visit once or twice a day? Is the loss more than offset by gains in safety and shortened length of hospital stay? What sort of relationship is possible between the patient and hospitalist, who has the best interest of many patients on his or her mind at the same time? Finally and importantly, how do these new focused-practice physicians relate professionally to their patients' primary care physicians, and how do they demonstrate to their profession and the public that they have the special knowledge and skills needed to care for people who are very sick?

In VM's first clinical case, two physicians, a hospitalist and a primary care physician, differ on a patient's treatment plan. Commentator Dawn Brezina, a hospitalist and educator at Duke University Health System, explains that hospitalists must constantly be on guard against conflict between the interests of the patient and those of the hospital, since a compromise in treatment plan may be a breach of obligations to the patient.

The next clinical case examines the new questions in professional relationships introduced by the hospitalist movement. When both hospitalist and family physician are involved, who is better suited to initiate a discussion about end-of-life issues? Mary Ehlenbach argues that the hospitalist may have greater skill in conducting such intense conversations, but she acknowledges and welcomes the participation of a family physician who has a long and close association with the patients who are facing the difficult decision.

Laborists, a subset of hospitalists, are the subjects of clinical case three. Laborists' expertise can add to patient safety in many labor and delivery cases, but they have “a duty to preserve the established relationship between the treating obstetrician and patient.” By doing so, Louise P. King and George D. Wendel Jr. maintain, laborists can preserve continuity of care even in emergent situations.

How do hospitalists demonstrate their competence? Jeffrey G. Wiese, a medical educator at Tulane University, explains the effort under way to assure that all hospitalists are trained to high standards. A “focused-practice certification” is planned by the American Board of Medical Specialties, the main tenets of which are that “physicians must (1) demonstrate competence as internists, and (2) have practice experience in hospital medicine.”

Robert M. Wachter is, by all accounts, a founder of the field. He summarized the key developments in hospital medicine in his 2008 article, The State of Hospital Medicine in 2008, which is reviewed by AMA intern Chloe White in this month's journal discussion.

The clinical pearl guides us through the benefits and limitations of transjugular intrahepatic portosystemic shunts (TIPS) in treating portal hypertension—the source of controversy in clinical case one. A physician training to be a transplant hepatologist, Elizabeth C. Verna encapsulates the most important indications and counterindications for use of this procedure.
In the health law article, Erin A. Egan uses Domby v. Moritz to show how the limits of hospitalists' liability are being defined—a vital step if this medical model is to survive legal challenges.

If hospitalists are so great, why not make their use mandatory? In this month's policy forum, Marc B. Royo, Laura L. Kimberly, and Alexandria Skoufalos, all from Jefferson Medical College of Thomas Jefferson University, in Philadelphia, explore why this option was tried in some places and then modified in the course of the field's evolution.

How far can the hospitalist concept go? C. Edward Wells confides the concerns that laborists—hospitalists who oversee labor and delivery—have about patient acceptance of their role, new in the past five years, in one of this month's history of medicine articles.

Another historical look highlights the rapid evolution of hospitalist medicine as a “site-of-care” specialty—a rise far more rapid than that of emergency medicine, the other well-known example of site-specific practice. Joseph Ming Wah Li explains the two key reasons for its birth and growth: efficiency and patient safety.

In the medicine and society section, Elmer Abbo discusses the new paradigm of health care delivery. He argues that physicians who practice in hospitals day in and day out are best positioned to mediate the inevitable conflict between an individual patient's needs and scarce resources. Dr. Abbo views the model of hospitalist medicine as central to a realistic medical ethics in our health care system.

While the profession has become accustomed to working with these new colleagues in the hospitalist field, there's still an element—part nostalgia, part unease—that says, “Something's not right. What happened to the old-time family doctor?” Robert M. Centor writes an op-ed article on the adjustments that are yet to be made. “I have heard tales of horrible hospitalists with lousy bedside manners. I have heard praise for wonderful hospitalists with superb bedside manners.” He is well placed to comment, having made the transition to hospital-based medicine himself.

We hope that this issue of Virtual Mentor helps readers understand the causes, outcomes, and ethical concerns raised by a revolution in hospital medicine so quiet that many may have not known it was occurring. Finally, we thank Erin A. Egan for the idea that led to this theme issue.


Sincerely,
Philip A. Perry, MSJJenny SchooleyFaith L. Lagay, PhD
Virtual Mentor editors

Is your parent overmedicated?

Use of multiple drugs, especially in older adults, can exacerbate ailments

By Siri Carpenter

Prevention

updated 8:34 a.m. ET, Mon., Nov. 17, 2008


About a year ago, my mother told my father there was a movie she really wanted to see and suggested they catch it that evening. Great idea — except that, as my dad gently reminded her, they had just seen it.

Though he tried to make light of it at the time, Mom's memory lapse was not an isolated event. She often repeated herself, misplaced one thing after another, and neglected commitments she didn't remember making. A woman with a gift for banter, she now found it difficult to carry on a conversation because she was so easily distracted. Most disturbing of all: She was only 61.

Mom, too, sensed something was wrong.

A teacher of English as a second language, she was known for her supple mind but now felt as if her brain was shrouded in fog. "I'm not as smart as I used to be," she told me recently. Fearing she might be suffering from some kind of early onset dementia, she made an appointment with a neuropsychologist and asked me to go with her.

I said I would, even though I suspected another culprit: the potent brew of medications she was taking for the litany of medical problems that has plagued her for years. She consumed so many drugs every day — 21 of them, prescribed to her by five different physicians—that she lugged them around in a toolbox. A partial list: two blood pressure medications, four for asthma, a cholesterol-lowering statin, and several others to treat her diabetes, fibromyalgia, depression, fatigue, and acid reflux. I assumed that, to coordinate this chemical assault upon her ailments, my mom's doctors talked to each other regularly, that her internist was closely monitoring her medications to prevent any dangerous interactions, and that every pill Mom popped was part of a carefully crafted treatment plan.

How naive.

When I took my mom to see the neuropsychologist, I was startled to learn just how naive my assumption was. The specialist dismissed outright my suggestion that polypharmacy (the use of multiple meds) might be to blame for Mom's porous memory and perhaps some of her other ailments as well. Without even knowing what my mom was taking (never mind the sheer quantity), she confidently asserted that drug-related problems come on more suddenly. I'm not a medical doctor, either, but I do have a PhD in psychology and know that complex situations can be unpredictable. The neuropsychologist's blithe dismissal irked me, so I did some research on my own.

Here's what I learned: The use of multiple, often unnecessary medications — especially among older people — is an entrenched, escalating, frightening, and mostly unexamined problem in modern health care. Although medications can ease many conditions, multiple-drug use often exacerbates existing ailments and causes troubling side effects that are treated with yet more drugs. Many doctors, researchers, and pharmacists I talked to agree. "Overmedication is a true epidemic," says Armon B. Neel Jr., PharmD, a clinical pharmacist in Georgia who evaluates medication plans for private and nursing home clients. "It's completely out of hand."

I also learned that, with the help of professionals, a determined patient can dramatically scale back her prescription drug use and eliminate, or at least reduce, the jumble of side effects that has clearly contributed to her downward spiral. That's what my mom did, emerging from her med-induced fog to reclaim her former vibrant self. This is the story of her comeback — a cautionary tale for everyone who takes several medications every day.

What's behind the Rx cascade

Polypharmacy is most common among people over age 65, about one-fifth of whom take at least 10 medications a week. Because the body absorbs, metabolizes, and rids itself of drugs more slowly with age, a dose considered safe for a middle-age woman can be toxic to her parent. In fact, the Institute of Medicine estimates that at least 1.5 million adverse drug events occur in the United States every year, thousands of them fatal. Studies indicate that about one-third of these drug reactions among senior citizens — and 42 percent of serious, life-threatening, or fatal events — are preventable. Doctors often mistake the ensuing physical response — memory lapse, fatigue, abdominal pain, swelling, or other ailments — as a sign of worsening disease. This can lead to a "prescribing cascade," says Jeffrey Delafuente, FCCP, a professor of pharmacy at Virginia Commonwealth University. "The solution is to reduce the number of drugs. Adding more just exacerbates the problem."

Seeing various doctors or specialists contributes to that cascade. According to the Agency for Healthcare Research and Quality, 81 percent of people with serious chronic conditions have two or more physicians, more than half have three or more, and a third have four or more. Specialists don't always know everything a patient is already taking, says Paul Takahashi, MD, a geriatrician at the Mayo Clinic. Primary care physicians are supposed to oversee the management of their patients' various medications, he says, but unless a new drug is clearly contraindicated, they're often reluctant to second-guess specialists' decisions. To be fair, doctors are not entirely to blame for rampant over-prescribing. In recent years, federal health panels have handed down more stringent targets for controlling chronic diseases such as hypertension and high cholesterol. Medication is often the quickest and surest way to get results — a strategy endorsed by insurance companies, which are reluctant to pay for less well-documented natural therapies.

Patients, too, unwittingly compound their own problems. "As a culture, we've come to expect that there's a pill for every ailment," says Stephen Bartels, MD, director of Dartmouth Medical School's Centers for Health and Aging. "Patients ask for medications they've seen advertised, and sometimes it's easiest for physicians to just prescribe them rather than encourage behavioral changes or preventive steps." Each added prescription increases the likelihood not only of a problematic interaction but also of misuse. Studies show that half of older people sometimes fail to follow their Rx instructions. It's no wonder. Consider my mom's regimen: She took 32 pills a day, at five different times — some once a day, some twice, some three times, and some as needed. One pill had to be split in half for the morning dose but not for the evening dose. Some were taken with food, others on an empty stomach. She also used three different asthma inhalers plus a nebulizer, all on different schedules. I'm half her age, and I couldn't keep that straight.

The more I learned about the risks inherent in taking a large number of prescription drugs, the more I saw how systemic the problem is. Seniors with five or more chronic health problems account for two-thirds of Medicare spending, yet doctors lack clear, evidence-based guidelines for coordinating their medications. A kind of head-in-sand ignorance is built into the system: Patients with multiple diseases are typically excluded from studies of a drug's safety and effectiveness, says Johns Hopkins geriatrician Cynthia Boyd, MD, MPH — and therefore are mostly ignored in the accepted guidelines that evolve from that research. "Every physician in the country is seeing these complex patients," she says, "but we have a long way to go in understanding how to integrate their care."

Paring down, one pill at a time

After our dispiriting visit with the neuropsychologist, who ordered tests, I wished my mom could go off most of her medications and just start over. Experts I interviewed said they could often simplify a patient's regimen but that changes are usually modest. I didn't think it would help her to go from 21 medications to, say, 19.

But I soon learned that some pharmacists, who typically know the products they dispense better than doctors do, often recommend more substantial changes. Neel, the Georgia consultant pharmacist, told me about patients who went from taking a dozen or more prescriptions to only a few, with marked improvements in health and quality of life. Sometimes, he said, removing just one inappropriate medication can eliminate the need for several others. "You send me your mom's information, and I'll see if I can help," he urged me.

Before I did, though, I had to know that Neel wasn't a quack. I talked at length with a couple of his clients, including 71-year-old Carla Moore, who related this riveting story: She hired Neel several years ago after a series of medical misfortunes left her on 13 medications, yet feeling worse and worse. "Every time I told the doctor how terrible I felt," Moore told me, "he wrote another prescription." Her health deteriorated for months, to the point that she told her husband she hoped she'd die. When Moore stumbled across a magazine article that called Neel "the pharmacist who says no to drugs," she picked up the phone.

Neel's analysis of Moore's medications suggested that some were redundant, others probably unnecessary. Still others, he believed, were doing more harm than good. But when Moore brought Neel's report to her longtime internist, "he took one look at it and threw it across the room at me," Moore says. "'I can't believe you'd insult me like this,' he said, and dismissed me from his office." The doctor later sent Moore a registered letter telling her to find another physician. The next eight doctors Moore consulted wouldn't even look at Neel's report. The ninth one did, and readily agreed to write the prescriptions necessary for her to follow the recommendations. Within a week, Moore felt substantially better, and within a month she was back to her old self. These days, she takes three prescription drugs, a daily aspirin, and a few vitamins and minerals — and feels 15 years younger. She walks on a treadmill and lifts weights at the gym several times a week, and blood tests confirm she is in excellent health for her age.

I was buoyed by Moore's turnaround but dismayed by her struggle to regain control over her medical decisions. Would we encounter the same resistance from our doctors?

Despite our concerns, my mom and I decided to hire Neel. One evening, we dumped the pills from her toolbox onto my kitchen counter and started cataloging them, recording each one's strength and dosing instructions. We sent this information to Neel, along with numerous lab results; a log of my mom's recent blood pressure and glucose readings; and a thorough description of her symptoms, medical diagnoses, and history.

In the 29-page report Neel sent us a week later, he identified 27 drug interactions among my mom's medications, most of moderate or high severity. It turned out that seven of her medications — fully a third! — sometimes cause memory loss, confusion, or impaired cognition. Neel recommended lower dosages of some drugs, taking others at new times of the day, and dropping some altogether. Among the most important suggestions:

Drop two of her blood pressure medications, which he believed were causing my mom's chronic cough, for which she was taking four asthma drugs (although she was never actually tested for asthma). He also thought one of these drugs was contributing to my mom's debilitating fatigue and weakness. He recommended replacing them with two others.

Discontinue the statin, which he felt was causing or exacerbating her muscle pain, which had long been attributed to fibromyalgia. He recommended that she manage her lipids through diet, exercise, and B vitamins instead.

Stop taking the medication for acid reflux, which was preventing her body from breaking down certain drugs, including, crucially, the enteric aspirin she took for cardiac protection. He recommended she instead eat a probiotic yogurt several times a day.

Neel's report was dense and nuanced, but its message was clear: My mom's medications were making her sicker. She, like me, was inclined to follow his recommendations, but the truth is that making such radical changes was intimidating. What if we were wrong?

Nonetheless, we plunged ahead and booked an appointment with my mother's internist. To our relief, the doctor said the plan was worth trying. She emphasized, though, that if Mom intended to reduce her use of medications, especially those aimed at controlling cholesterol, blood pressure, and blood sugar, she'd have to exercise regularly and keep a close watch on her diet.

So we left the doctor's office with a handful of new prescriptions, feeling both relieved and apprehensive. That night, I hammered out a 10-page spreadsheet to help Mom keep track of her new schedule, which would change daily for 2 weeks, then every 10 days for another month. She now takes six daily medications, plus a few vitamins. Neel believes that in time, she may be able to eliminate still more drugs.

A promising new start

A few days into her new regimen, the fog that enveloped my mom's mind receded and her mood brightened. The asthmatic cough that plagued her for years has vanished, and recent tests showed normal lung function — no asthma after all. Her muscle pain has dramatically diminished. When I asked recently how her acid reflux was, she retorted, "What reflux?"

Five months into the routine, it's too early to say whether she can keep her blood sugar and cholesterol in check without more meds. Although her cardiologist is satisfied with her blood pressure, her internist is not. If her systolic reading isn't down to 120 by her next visit, the doctor insisted, "You're going back on the old drugs."

This encounter left my mom profoundly discouraged. She still believes she's better off without the drugs. With the assistance of a credentialed health care provider, she has dedicated months to gaining control over her health. She's accepted a marginally higher cardiac risk in order to avoid a multitude of symptoms that impeded her quality of life. But her doctor still holds the trump card: She could decline to write the prescriptions that would allow my mom to continue to follow Neel's recommendations, or even ask her to find another doctor. Afraid she'll be "fired," Mom wants to appease the doctor somehow — surely not a solid basis for making medical decisions.

Still, things are looking up. A year ago, Mom was a wreck. Now she's simply a middle-aged woman who has to watch her blood pressure and her blood sugar. That qualitative shift has given her a fresh outlook. "My life has changed and will continue to," she confidently declared recently. In the past several months, she has renewed her commitment to controlling her diabetes with a healthy diet and exercise. Last weekend, she and I took an overnight bike trip together.

There was no room on her bike for a toolbox filled with pills — and no need for one. The toolbox is history.