News & Views Newletter
edited by Jack Nicholas, cornishpro@aol.com

PSORIATIC ARTHRITIS NEWS AND VIEWS
VOL. 3 ISSUE 13 - July 31, 2003
PSORIATIC ARTHRITIS MEDICAL NEWS

AMGEN SUBMITS ENBREL FOR PSORIASIS INDICATION
Reuters Health Information 2003. © 2003 Reuters Ltd.

NEW YORK (Reuters) Jul 08 - Amgen Inc. said on Tuesday it submitted an application to regulators to market its rheumatoid arthritis drug, Enbrel, as a treatment for psoriasis.

Amgen, which markets the drug with Wyeth, said it has applied to the U.S. Food and Drug Administration to market Enbrel for moderate to severe plaque psoriasis, which affects some 7 million people in the United States.

Data released in March from a late-stage trial showed that the drug, which blocks tumor necrosis factor, improved symptoms by at least 75% in 49% of patients when given in high doses. A lower dose improved symptoms by 75% in 34% of patients.

Drug companies are eager to enter the psoriasis market. Regulators have already approved Amevive, a new drug from Biogen Inc., and other drugs are being developed by Genentech Inc. and its partner Xoma Ltd., Johnson & Johnson and Abbott Laboratories Inc.

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ONE IN THREE DOCTORS WITHHOLD INFORMATION
By Daniel DeNoon WebMD Medical News Reviewed By Brunilda Nazario, MD

July 10, 2003 -- One in three doctors do not tell patients about treatments their insurance doesn't cover.

That's a violation of doctors' ethical code, says Matthew Wynia, MD, MPH, director of the American Medical Association's Institute for Ethics. He led a team that surveyed 720 U.S. doctors. Their report appears in the July/August issue of Health Affairs.

And what they found is troubling:
31% of doctors sometimes don't offer useful care to a patient because of health plan rules. Nearly one in 10 doctors say they do this often or very often. 35% of the doctors who say they sometimes withhold information also say they do it more often than they did five years ago.

"One of the lessons we should take from this is the importance of doctors being honest with their patients and being open to commitment to the ethics of the profession," Wynia tells WebMD. "Our code of ethics is quite clear. A doctor must talk about all potentially useful services, regardless of whether they are covered by the patient's health plan."

It's a matter of respect for the patient and respect for the doctor's profession, says Ken Thorpe, PhD, professor of health policy at Atlanta's Emory University

"Of course doctors should tell their patients about all their options -- even if they are more expensive," Thorpe says. "What I find disturbing is, what do these doctors do when they have patients who are not insured? Do they not talk to them at all? A doctor needs to outline the full scope of treatment for a patient. Some of these treatments are fully reimbursed, some not. As long as patients have information on the costs and benefits of their treatment options, they can make their own decisions.

Most Information Withheld Doesn't Threaten Patients' Health: It's no excuse for violating their own ethical code, but doctors who withhold information often are just trying to help.

A common scenario, Wynia says, is a doctor who knows that a patient can get relief from an older drug that's given twice daily or a newer drug that's given once daily. If the doctor knows the new drug is very expensive -- and not covered by the patient's insurance -- he may not tell the patient about the new drug.

That's wrong -- but it avoids making patients feel bad about what they can't afford. It also avoids a tense conversation in which the patient may ask the doctor to bend the rules. Doctors know all about this -- they call it "gaming the system" -- and it, too, is unethical and sometimes illegal.

"It seems to me substantially less likely that a doctor would choose not to offer a really important service," Wynia says. "If it is really medically necessary, and you chose not to talk about it, and the patient finds out, you end up with a lawsuit. Nobody wants that. So we are probably talking more about the marginal benefit, where a service provides some utility but is not lifesaving."

That's paternalistic, says John D. Banja, PhD, a clinical ethicist at the Emory Center for Ethics in Public Policy and the Professions. Doctors shouldn't presume to know what patients can't afford or don't want to hear, he says. And the least they should do for a patient is the standard of care for their specialty.

"A doctor cannot expose a patient to harm, peril, or menace," Banja tells WebMD. "You can't turn your back on patients when they are needy."

And Banja makes another point. If treatments are truly needed, insurers are obliged to pay.

The Bottom Line: The Doctor-Patient Partnership
Wynia says that doctors make a bad choice when they withhold information from patients. But it's not all their fault.

"We are talking about a system that is broken," Wynia says. "It is broken when doctors and patients feel disempowered about coverage decisions. When we can't understand these decisions, this means they were made in ways we see as unfair or illegitimate. We need to work hard to make coverage decisions doctors and patients can live with without sacrificing our ethical obligations, our health, and our doctor-patient relationship."

For Wynia, that's the bottom line.

"The most troubling thing about this is that if someone finds out their doctor did not tell them of something, that can erode trust in their relationship. And that is the last thing we need," he says. "We need doctors and patients to work together, not to be wary of each other."

SOURCES: Health Affairs, July/August 2003. Matthew Wynia, MD, MPH, director, American Medical Association Institute for Ethics, Chicago. Ken Thorpe, PhD, professor of health policy, Emory University, Atlanta. John D. Banja, PhD, clinical ethicist, Emory Center for Ethics in Public Policy and the Professions,

Atlanta. © 2003 WebMD Inc.

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CAREGIVER'S STRESS ADDS TO AGING
By Sid Kirchheimer WebMD Medical News Reviewed By Charlotte Grayson, MD

June 30, 2003 -- It's no surprise that the stress of caring for a loved one with serious illness can age you before your time. And now, a new study suggests exactly how -- through a chemical reaction that weakens the body's immune system and accelerates the aging process.

During periods of stress, so-called "stress" hormones are released that trigger a cascade of physiologic changes. These include increased production of interleukin-6 (IL-6), an inflammatory chemical that has been linked to increased risk of heart disease, type 2 diabetes, osteoporosis, arthritis, and other conditions often associated with aging.

A new study suggests that caregivers' stress may make them especially vulnerable to these elevated IL-6 levels -- and arguably, these diseases.

Caregivers' Chemical Boost
Researchers report in this week's issue of the Proceedings of the National Academy of Sciences that study participants who cared for an Alzheimer's patient typically had blood levels of IL-6 four times as high as those who were not caregivers -- despite being otherwise similar in age, lifestyle, and income bracket.

What's more, these IL-6 levels in the caregivers remained high for up to three years -- even after their loved ones had died.

"One can suggest that an immune system that is naturally less efficient [at preventing disease] as you age may become permanently damaged and get to the point where it cannot recover from an insult like this," says researcher Ronald Glaser, PhD, of Ohio State University College of Medicine and its Institute for Behavioral Medicine Research. "And caregiving is certainly a stressful enough event to do that."

His study helps explain previous findings that caregivers typically suffer from impaired immunity, and therefore may be more vulnerable to various serious health problems compared with those under less stress. But it also suggests how quickly this type of major stress can age a caregiver.

People don't usually have the highest levels of IL-6 in the blood until they're about 90, Glaser tells WebMD. "In our study, we found those high levels in caregivers who were around age 75." His six-year study included 117 caregivers and 106 others, all between 55 and 89 but with an average age of about 70.

Interleukin-6 naturally increases with age, which is one reason why seniors tend to be more susceptible to disease. Regardless of age, high IL-6 levels are also associated with increased risk of heart disease, diabetes, osteoporosis, arthritis, and certain cancers, which typically happen after middle age, when immunity naturally weakens.

Other factors that increase production of IL-6 include obesity -- fat cells make this compound -- as well as smoking and poor sleep. Conversely, regular exercise can decrease IL-6 levels, says Glaser.

"This study is significant because IL-6 is probably the prototype that provides the link between stress and metabolic syndromes such as high blood pressure, diabetes, and obesity," says Paul J. Rosch, MD, a stress researcher for some 50 years who is president of the American Institute of Stress and a professor of medicine and psychiatry at New York Medical College. He was not involved in Glaser's study.

Relieving the Stress
Unfortunately, there is no one-remedy-fits-all for controlling stress. "But clearly, having a perceived sense of control is a powerful stress buster," says Rosch. The trick is to distinguish between the stressors that you have no control over and those that you do.

"I often have my patients make a list of all the events and people they find stressful and put them in two categories -- those can do something about, and those can't," he tells WebMD.

"If someone has died or is in failing health, there is nothing you can do about that, so there is no sense wasting your time and adding to your stress with 'what ifs'? On the other hand, if what is stressing you is that your 15-minute commute to work is taking an hour, you can approach your boss and suggest changing your work schedule to avoid rush hour, or see about working at home."

Because caregivers often feel they have no control over their stress, Glaser suggests they pay particular attention to another proven stress buster -- an active social network.

"In cases like this, you not only have the stress of seeing a loved one basically disappear before your lives as a person, but because of the nature of caregiving for an Alzheimer's patient, you lose your social network," he tells WebMD.

"And the way people cope through a variety of stressors is with social support. Since people with care-giving responsibilities tend to lose those networks, they really need to make an effort to seek out their friends, join support groups, or just arrange to get away and out of the house."

SOURCES: Proceedings of the National Academy of Sciences, June 30-July 3, 2003. Ronald Glaser, PhD, professor of molecular virology, immunology and medical genetics, Ohio State University College of Medicine and the Institute for Behavioral Medicine Research, Columbus. Paul J. Rosch, MD, president, the American Institute of Stress, Yonkers, N.Y.; professor of medicine and psychiatry, New York Medical College, Valhalla, N.Y. © 2003 WebMD Inc.

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GREAT HUSBAND? THANK YOUR MOTHER-IN-LAW
By E. J. Mundell NEW YORK (Reuters Health)

Stereotypes of the nagging, critical mother-in-law may need some revising: A new study suggests that good husbands or boyfriends are often the product of great moms.

Researchers interviewing 33 young couples found "significant" correlations between men's ties to their mothers and their partners' satisfaction with the relationship.

"If he's very close to his mother he may feel very close to his partner, probably very affectionate," explained researcher Sarah Roberts, of Ferrum College in Virginia.

Roberts co-authored the study with psychologist Sharon Stein while an undergraduate at Ferrum. She presented the findings at the recent annual meeting of the American Psychological Society, in Atlanta.

Although much research has been conducted into the parent-child relationship, Roberts and Stein say the impact of the mother-son relationship on a son's significant other has been "overlooked."

In their study -- titled "Mama's Boy or Lady's Man?" -- the two researchers had each male and female partner in 33 couples fill out separate questionnaires.

"The questionnaire that was given to the women was about relationship satisfaction," Roberts said, "and that given to the men was about their perceived closeness to their mothers."

The researchers found that, in general, men who said they had moms who "understood their needs" had mates who described them as "affectionate." Men who had a strong love for their mothers also tended to date women who described them as not only their lover, but also "their best friend," the authors report.

Finally, men who said they sought to "make their mother proud" ranked high in terms of their ability to communicate with their female partner.

How might mothers mold the attitudes and conduct of their male offspring when it comes to adult romantic relationships?

"In traditional homes, the mother is the very first person that the children have (as their) introduction to femininity," Roberts said in an interview with Reuters Health. "Their mother is, for the male child, their first study of what a woman is. So of course they watch her behaviors, they watch certain things coming from her, and of course are influenced by everything she may teach them."

Besides influencing him to be more open and gentle with others, an attentive mother may even influence her son's choice of mate in later life.

"If the mother is very loving, very caring, and displays this to her son, he may be in a position where he's thinking, 'Well, I want a woman like my mother,' or 'I don't want a woman like my mother,'" Roberts said.

But of course this influence can go overboard, too. For example, in a surprise finding, men who claimed mom as "their best friend" or said they "enjoyed spending time with mom" also tended to be labeled as less-than-considerate by many of their mates.

So a mom's love can backfire, too.

"I think it's clear it can go either way," Roberts said. "There's the question of 'how much is too much?' If he's too close to his mother, might not that be an obstacle for his spouse?" Copyright © 2003 Reuters Limited.

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RHEUMATOID ARTHRITIS PATIENTS CAUGHT IN THE MIDDLE OF DOCTOR'S DISAGREEMENT OVER HAND SURGERY LARGE STUDY NEEDED TO SETTLE THE ISSUE, UNIVERSITY 0F MICHIGAN TEAM SAYS

ANN ARBOR, MI July 2003
More than two million Americans with rheumatoid arthritis are caught in the middle of a debate among physicians over which treatment - medications or hand surgery - will help their ravaged fingers and wrists most.

And a new University of Michigan Health System study finds that entrenched attitudes and lack of communication among rheumatologists and hand surgeons, and a dearth of data comparing the two strategies, are keeping the controversy going.

Only large studies evaluating the effectiveness of various hand operations, the researchers say, will quell the debate and help patients get consistent and beneficial care no matter what kind of doctor they see or where they live.

The multidisciplinary U-M research team reports its latest findings about attitudes among rheumatologists and surgeons in the current issue of the Journal of Rheumatology. They published previous attitude-related results in the Journal of Hand Surgery earlier this year, and last October they reported dramatic state-by-state variation in hand surgery rates in the journal Arthritis & Rheumatism.

"What we're finding is that rheumatoid arthritis care can vary tremendously depending on where patients live, what type of physician they're referred to, how much cross-training and interaction those physicians have with others, and what an individual doctor personally thinks of other specialties," says Amy Alderman, M.D., M.P.H., lead author of all three studies and a resident in Plastic & Reconstructive surgery at UMHS. "Since this is a debilitating, chronic condition that affects so many, it's very concerning that we don't have a consensus or communication among providers."

Alderman and her U-M colleagues - who include a rheumatologist, a senior hand surgeon, general internists and a statistician - surveyed nearly 1,000 doctors selected by random sampling from among the members of top rheumatology and hand surgery societies. For the October paper, they also analyzed data on numbers of hand operations performed on rheumatoid arthritis patients in each state, compared with the number of people diagnosed with the condition overall. v "We see dramatic differences of opinion and practice over an important clinical problem that will only increase in importance as the population grows older," says co-author Peter Ubel, M.D., associate professor of internal medicine and psychology. "We don't know yet what will work best for individual patients, and so physicians don't agree about the best way to treat this condition. Patients need to be aware of this, and they may need to talk to several doctors to decide what's right for them."

Rheumatoid arthritis affects about 1 percent of the American population, and causes prolonged, painful and often debilitating inflammation and deformity in joints and tendons. Caused by a mysterious autoimmune malfunction, it affects patients for the rest of their lives, often worsening year by year. The condition especially strikes the hands and wrists, where it has a major impact on a patient's ability to perform daily functions such as lifting, eating, personal care and writing.

Medications have long been used to reduce inflammation, and work for many patients for years after diagnosis. But hand surgery has been seen as an option for patients who do not respond to medicines or whose hands have become so twisted and contorted that they no longer work.

The U-M survey studies show that physicians of different specialties are miles apart in their perception of how well surgery can help ease pain, restore function and prevent further problems. And, they're just as divided over how well they think members of the opposite specialty do at managing rheumatoid arthritis patients.

For instance, in the newly published paper, 70 percent of the rheumatologists surveyed considered hand surgeons deficient in their understanding of the non-surgical treatment options for rheumatoid arthritis, while 73.6 percent of the surgeons thought rheumatologists didn't know enough about the surgical options available to their patients.

The two groups of doctors differed significantly in their opinions of when particular operations might be appropriate for particular patients. Presented with case studies of hypothetical patients, they disagreed across the board on when joint replacement (arthroplasty), joint lining removal (synovectomy) and wrist bone surgery (resection of distal ulna) were indicated.

In the Journal of Hand Surgery paper published earlier this year, the U-M team found that the two types of doctors differed greatly on their perceptions of what surgery could actually do for patients. More than 82 percent of the hand surgeons, for example, felt that joint replacement improves hand function, as opposed to 34 percent of rheumatologists.

Meanwhile, 93 percent of the surgeons thought that removing the sheath around a tendon (tenosynovectomy) could prevent future ruptures of the tendon, compared with 54 percent of rheumatologists. And 52 percent of surgeons felt that small-joint synovectomy could delay the destruction of a knuckle joint, compared with 12 percent of rheumatologists. Thirty-five percent of rheumatologists felt that operation was never a good idea for patients.

These different world views on surgery are reflected in the state-by-state variation in surgery for rheumatoid arthritis that the researchers reported last fall. They found that some operations were performed as much as 12 times more often in some states than in others.

The different "management concepts" that rheumatologists and hand surgeons have for rheumatoid arthritis patients are only further divided by the fact that specialists in the two fields tend to read and publish research findings in their own field's journals, says Alderman.

And, she notes, only small uncontrolled studies have been performed to see how well the different operations work to repair arthritis-damaged hands or prevent more damage. Larger studies, aimed at measuring outcomes for different operations performed at different times, are needed. At the same time, plenty of such data are available for new medications that have come on the market in recent years - data from the major controlled studies required for drug approval by the U.S. Food and Drug Administration.

As those new medications come into widespread use to help control the damage caused by the inflammation of rheumatoid arthritis and prevent progression of the disease, fewer patients may need early, aggressive surgery that preventively removes joint linings, Alderman notes.

But more may eventually need joint replacement or synovial surgery after medications start losing their effectiveness - and the speed with which they get that surgery may have a lasting impact on how well their hands regain function.

That means communication between specialists will become more important than ever - but at the moment, the U-M studies seem to indicate that the two fields aren't talking with each other.

The new paper shows that 67 percent of hand surgeons and 79 percent of rheumatologists had no exposure to the other specialty during their medical training, and only about 10 percent of the physicians worked in combined-specialty hand clinics. And only 62 percent of all the physicians said they communicate with the other specialist treating a patient when they disagree with how a patient's care is being managed by that doctor.

The U-M Medical School is trying to bridge the gap in cross-training, by exposing medical residents in surgery and rheumatology to the other specialty during joint sessions.

All in all, say the authors, patients need to ask about all possible treatment options when they see primary care doctors and specialists, and decide what's right for them based on the level of their symptoms and the response to medications.

"Health care providers treating the rheumatoid arthritis population must recognize that they provide uncoordinated care, and work to improve quality of care through collaboration," says Alderman. "To create a coordinated approach, we need an international effort to collect solid data on surgical outcomes, disseminate the data to members of both specialties and to primary care providers, and design treatment plans tailored to specific disease characteristics."

The U-M researchers also hope they'll be able to help gather the data needed to prove surgery's effectiveness, and the best timing for certain operations. Kevin C. Chung, M.D., M.S., an associate professor of plastic and reconstructive surgery and the hand surgeon in these publications, will be leading a team of international researchers to study outcomes of surgical procedures in the rheumatoid population. These studies will be an important first step to bridge the gap between the two specialties.

In addition to Alderman, Chung and Ubel, the new paper's authors include David A. Fox, M.D., professor and chief of rheumatology; and H. Myra Kim, Sc.D., an associate research scientist in the biostatistics division of the U-M School of Public Health.

The study was supported in part by a grant from the Robert Wood Johnson Foundation and the American Society for Surgery of the Hand. Alderman is a former Robert Wood Johnson Clinical Scholar at the University of Michigan, and was mentored by Ubel, who also directs the Program for Understanding Health Care Decisions at the U-M Medical School.

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FDA PANEL BACKS NEW STATIN DRUG
By Jennifer Warner WebMD Medical News - July 9, 2003
Reviewed By Brunilda Nazario, MD

An FDA advisory panel today unanimously recommended the approval of Crestor, a new drug that belongs to a class of widely used cholesterol-lowering drugs called statins. The FDA is not required to follow the advice of the advisory committee when making its final decision, but it usually does.

The approval process for Crestor stalled in recent months after concerns arose regarding a rare but potentially deadly muscle-damaging side effect of statins known as rhabdomyolysis. In February, the FDA requested that the drug's manufacturer, AstraZeneca, submit additional clinical trial information about the safety of Crestor.

Crestor was dubbed the "superstatin" after initial studies of the drug using a standard statin dose of 80 mg showed it was considerably more powerful than other statins at reducing the "bad" LDL cholesterol. But those studies also found that the 80 mg dose was associated with a higher rate of muscle damage.

At today's meeting, AstraZeneca presented new information about the safety and effectiveness of Crestor when given at lower doses. The advisory panel recommended that the FDA approve Crestor for use at doses ranging from 5 mg to 40 mg per day.

The phase III "Stellar" clinical trial found that 10-40 mg doses of Crestor reduced LDL cholesterol levels by 46%-55% in people with elevated levels of LDL and increased levels of the "good" HDL cholesterol by 7.6%-9.6% in people with low levels of HDL.

Crestor vs. Other Statins
Five other statins are already approved to treat high cholesterol, including Lescol, Lipitor, Mevacor, Pravachol, and Zocor.

The six-week Stellar study compared the lower dose of Crestor to 10-80 mg doses of Lipitor and Zocor and a 10-40 mg dose of Pravachol. Compared with the 46%-55% reduction in LDL cholesterol levels found with Crestor, Lipitor lowered LDL by 37%-51%, Zocor by 28%-46%, and Pravachol by 20%-30%.

The other statins also increased HDL cholesterol by 3.2%-6.8% vs. the 7.6%-9.6% improvement found with Crestor.

"It does appear from the data that's been published that the 40 mg dose of [Crestor] is slightly more effective at lowering LDL than the 80 mg of [Lipitor]

and the highest dose of any of the other statins, but the difference is not large," says Richard Pasternak, MD, director of preventive cardiology at Massachusetts General Hospital and associate professor of medicine at Harvard University. "Whether that will translate into an important addition or not I think remains to be seen."

According to those results, Pasternak doesn't think the approval of Crestor will necessarily send people with high cholesterol running to their doctor's office for a new statin prescription or to change their current statin.

"I think the extent to which people run into doctor's offices for either of those will depend on the ability of AstraZeneca's marketing team, not on new science," Pasternak tells WebMD.

The Baycol Backlash
In August 2001, another statin, Baycol, was voluntarily withdrawn from the market after 31 deaths were linked to muscle damage caused by the drug. Since then, the FDA has taken a harder look at the safety profile of statins already in use as well as those new statins submitted for approval.

"Do we really need another statin?" says Pasternak. "We have five, and we already have had one withdrawn. The FDA certainly doesn't want to be in the position of approving one that needs to be withdrawn later. I think the bar for approval, particularly around safety issues, is likely higher than it's been in the past because we do have alternative therapies that work very well and are very safe."

But the drug's makers say Crestor will provide a valuable alternative for the millions who are currently using statins and millions more who might benefit from treatment with cholesterol-lowering therapy.

"We believe that once approved, Crestor will provide patients who are untreated or not at their target cholesterol levels with an important new treatment option in the control of elevated cholesterol," says Howard Hutchinson, vice president of clinical research at AstraZeneca, in a news release.

According to a joint report on statins issued last year by the American Heart Association, American College of Cardiology, and the National Heart, Lung and Blood Institute, the cholesterol-lowering drugs are underused and hold great promise for reducing heart-related problems and stroke.

Overall, researchers say statins have proven to be extremely safe in the vast majority of patients receiving them. But certain people may face a higher risk of adverse side effects from statin use, including:

Those over age 80, especially older women. Frail individuals with slight body types. Those with multisystem disease, such as diabetes-related kidney disease. People taking other medications that might interact with statins, such as fibrates (including Lopid), HIV protease inhibitors, and cyclosporine and certain other types of antibiotics. Persons about to undergo surgery. Those who abuse alcohol.

SOURCES: FDA. Richard Pasternak, MD, director of preventive cardiology, Massachusetts General Hospital; associate professor of medicine, Harvard Medical School. News release, AstraZeneca. ACC/AHA/NHLBI Clinical Advisory on the Use and Safety of Statins. WebMD Medical News: "New Drug Takes a Sledgehammer to High Cholesterol." WebMD Medical News: "Cholesterol-Lowering Drug Baycol Pulled Off the Market." © 2003 WebMD Inc.

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Surround yourself with what you love, whether it's family, pets, keepsakes, music, plants, hobbies, whatever. Your home is your refuge.

Good Health to All,

Jack Nicholas
Newsletter Editor
Cornishpro@aol.com
Issue 2003 7/31/03-13