January 1999

International

• Mighty Mouse Illustrates Strength in Gene Therapy 
• The Hidden Epidemic 

National

• Penn Report Targets Bad Study Habits
• Plans Focus on Patients, Not Profits
• The Kidney Case: Is It Ethical?    

Local

• They Need Your Support

Perspectives

Snips & Clips

Two medical developments in 1998 proved good news to older Americans. First came Viagra, marking a return for many to active sex lives. In December, news broke of an advance that someday could mark their return to the gym. 

Penn scientists have developed a novel gene therapy treatment that permanently blocks the age-related loss of muscle size and strength in mice. Mice, like humans and all mammals, lose up to a third of their muscle mass and power with age. In humans, the result is an advancing weakness in the elderly that can lead to unsteadiness and impaired mobility, increased susceptibility to falls and injury, and joint stress and degeneration. 

The study was published in the December 22 Proceedings of the National Academy of Sciences.

“Our results show that it may be possible to preserve muscle size and strength in old age using this approach,” H. Lee Sweeney, PhD, professor of physiology and senior investigator on the study, told the New Scientist. “We’re now looking to see whether the technique might also be used to increase muscle strength in diseases such as muscular dystrophy.” 

Even in young adult mice, the new treatment increased muscle strength by a dramatic 15 percent over untreated muscle. But in older mice, the improvement was even more remarkable: The researchers documented a 27 percent boost in strength over untreated muscle in these mice—fully restoring their strength to what it was in young adulthood. 

The researchers manipulated an adeno-associated virus—known to be highly efficient at introducing its genes into target cells—so that it delivered a gene involved in muscle repair and regeneration. The investigators then injected the engineered virus into the muscles of the mice. 

The researchers theorized that muscle wasting was not due to an impairment in the repair process, but due to a diminished ability on the part of the muscle cells to invoke it. This gene therapy treatment switched on the chemical signal that triggers the repair process. 

If this work is to be extended into humans, a number of ethical considerations will need to be addressed, according to senior author Sweeney: “The beneficial effects of this gene therapy could easily be used in humans for athletic or even cosmetic enhancements and not only for limiting age-related muscle loss or for treating diseases of the muscle.”

Reports began December 14. 

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Penn researchers have come up with some unsettling statistics. And they’re wielding them to urge doctors, schools, and parents to confront a painful reality: One in six boys in America have been sexually abused. 
Their research suggests that boys who are sexually abused are far more likely to struggle with drug addictions and mental illness . . . and often become sexual predators themselves. The study, led by William Holmes, MD, assistant professor of internal medicine, and Gail Slap, MD, director of HUP’s Adolescent Medicine Program, appeared in the December 2 Journal of the American Medical Association.

“If you want to draw a parallel,” Holmes told The Philadelphia Inquirer, “one in eight women will develop breast cancer and we pay a lot of attention to that. A very similar number—if not more—of boys will be sexually abused. How often do you hear about that?” 

The researchers reviewed and compared 166 previously published studies of the topic. They found that 8 percent to 16 percent of the general male population had a history of sexual abuse; boys at higher risk were younger than 13, nonwhite, poor, and not living with their fathers. Perpetrators tended to be known, but unrelated, males. Abuse frequently occurred outside the home, involved penetration, and occurred more than once. 

Equally disturbing are the far-reaching consequences of the abuse. “In the sixth grade, the rate of using alcohol and cocaine and marijuana and intravenous drugs are up to 25 to 50 times higher for boys who have been sexually abused than for boys who have not,” Holmes told the Inquirer. “Boys who are sexually abused have up to 12 times the suicide rates as boys who have not been abused.” 

Given that boyhood sexual abuse manifests itself in so many destructive behaviors, the researchers say it’s time to begin raising the public’s awareness of the issue. “Parents have to start warning their boys about these potentials,” said Holmes. “They need to talk to their boys about who they’re with, where they’re going, what’s been going on, how they’re feeling, and in general create an environment for their boys where their boys feel as comfortable as their girls to coming to them and telling about what’s been going on.” 

Reports began December 2. 

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A report co-authored by Penn Center for Bioethics Director Arthur L. Caplan, PhD, paints a woeful state of affairs in medical studies, concluding that study subjects are inadequately protected from risks, hazards are often poorly explained, and scientists are often in conflicts of interest. The report was published in the December 8 Journal of the American Medical Association. 

“Right now, research protection in the United States is better for animals than it is for people,” Caplan told The Orange County Register. “The current system is straining and in danger of falling apart,” he added in The Seattle Times. “It costs too much, is too bureaucratic, and doesn’t give the kind of protection to subjects that people have a right to expect.” 

Regulations in use today were developed 17 years ago by the Department of Health and Human Services and the FDA, and they only apply to government-funded research. “If you’re privately funded, you can ignore all those rules, and that’s a major problem,” said Caplan. 

Other concerns noted in the report: Medical centers increasingly get funding from drug companies and other for-profit entities rather than the federal government. Concerns have mounted that researchers may be paid by the number of subjects they enroll, which gives them an incentive to put the sponsor’s interest ahead of the subjects’ interests. And the long, technical, and abstractly written forms used to obtain subjects’ consent to be studied have, said Caplan, “become vehicles for reducing legal liability for researchers and institutions, rather than empowering subjects to make good choices about being in research.” 

Caplan said people who serve on institutional review boards need to get out of board rooms and talk with study subjects, a goal that their heavy bureaucratic workloads may currently make impossible. He also recommends that the review boards adopt a random audit system, much like the Internal Revenue Service, to routinely monitor a certain percentage of studies. “Even if you only did 2 or 3 percent,” Caplan said, “you’d let the bad apples know you’re out there.” 

Reports began December 8. 

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The key to improving health and reducing costs lies in making good medicine, not cost-cutting, the priority, David J. Shulkin, MD, chief medical officer and chief quality officer for the Health System, told the Times. “We’re implementing best practices and letting the economics sort itself out.” 

At Penn, disease management is yielding significant results. Of 1,547 patients with hypertension, Shulkin said, only 19 percent had blood pressure at or below 140/90 when they enrolled in the program, but 53 percent achieved those levels afterward. Of 1,497 with adult diabetes, 40 percent had safe levels of blood sugar before enrollment; afterward, the figure was 60 percent. 

The Times noted that many management programs affecting large numbers of patients can cost more to operate than they save. “But when you balance out the winners and the losers,” Shulkin said, “it turns out to be a significant cost-saver overall.”

Penn offers disease management programs for 20 chronic conditions through its 85 physician practices in and around Philadelphia. One featured in the Times was the clinic in West Chester, where 11-year-old Nick Polidore is treated for asthma. Before family doctor Brandt S. Loev, MD, examined him, Polidore saw Wendy York, the resident disease management coordinator and patient educator. York retrieved the boy’s chart, collected specialized forms to guide Loev, conducted a pulmonary function test, and counseled the boy on using inhalers, nebulizers, and bronchodilator and in giving himself emergency epinephrine shots to open breathing passages. She also had him demonstrate how to use a meter that measures his breathing. 

Like many patients under disease management, he plays a role in managing his own disease. “He’s a classic case,” said Loev. “Our emergency room costs are lower. Our hospital costs are lower. The patient is much more in control. And the patient who comes in isn’t as sick.” 

Printed December 7.

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Three years ago, David Patterson donated a kidney to his sick daughter, Renada. Now that kidney is failing and Patterson wants to give the teenager his remaining kidney, a move that could threaten his life. An ethics panel at the University of California, San Francisco, is reviewing the unprecedented request. 

At issue: Is it acceptable for someone to sacrifice his own future for someone else’s through organ transplantation? Penn Center for Bioethics Director Arthur L. Caplan, PhD, rejects the idea. “As commendable and as altruistic as this man’s offer is, we simply cannot allow medicine to dictate whose life is worth saving,” Caplan told The Sacramento Bee. “No program would, or should, remove a second kidney under any circumstances from a live volunteer. It’s too enormous a risk to the donor.” 

Patterson, 37, could survive for a time without kidneys. Dialysis machines filter toxins from the blood mechanically. But his health would be constantly threatened and his life undoubtedly shortened. Certain factors further complicate the situation: Patterson is serving a prison sentence for burglary. Tired of uncomfortable side effects, Renada secretly stopped taking the powerful drugs that stave off rejection some time last year. 

“Not only using the second kidney, but using it in a situation where someone has gone off their medicine, who has shown herself noncompliant, would be a gross violation of medical ethics,” Caplan told The New York Times. 

Other options are open to Renada. Though kidney transplants from living, related donors are the most successful, she could still receive a kidney from an unrelated donor with similar blood characteristics, or from a cadaver.  

Reports began December 5.

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Bipolar disorder, characterized by dramatic mood swings, affects about 3 percent of the U.S. population. About 60 percent of sufferers either receive incorrect treatment or no treatment at all.  

But increased awareness of the disorder, along with new treatments and medications, is making a difference, Laszlo Gyulai, MD, assistant professor of psychiatry and director of Penn’s Mood and Anxiety Disorders Program, told the Daily Local News: “With proper attention and medication, patients can live a full, productive life, but it requires psychosocial intervention, education, and a lifelong attentiveness to the problems.”

Gyulai detailed the diagnosis and treatment of bipolar disorder this fall for New Directions Delaware, Inc., a support group for those with manic depression and their families.

Gyulai stressed the role of family in a patient’s treatment.“People suffering from these disorders often don’t seek treatment for years. As a result, lot of negative feelings have accumulated, partly in themselves and partly in their families. 

“Unfortunately, by the time a patient comes in for treatment, the family structure is usually already broken and that has to be fixed. A lot of things have happened to their souls, to their minds.” Gyulai’s message: Along with correct diagnosis and continuing medication, family support is essential. 

Printed November 23. 

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“What are the limits? How far will this go? It’s brute-force biology. You see what can be done, and then you do it.” 
— Glenn McGee, PhD, professor of bioethics at Penn’s Center for Bioethics
“Experts Skeptical Cloning of Humans Could Be Prevented”
The Philadelphia Inquirer, 11/18

“I’m embarrassed to say that there are children who leave the parking lot at Children’s Hospital of Philadelphia unrestrained.” 
— Flaura K. Winston, MD, PhD, assistant professor of pediatrics 
[Subject: The correct use of child seats.] 
The Detroit News, 12/7

“He was the most compassionate and brilliant physician I ever met. The way he presented himself at the bedside could serve as a stand-alone course in how to interact with a patient.” 
— Steven L. Galetta, MD, professor of neurology
[Subject: Obituary for Eric C. Raps, MD.]
The Philadelphia Inquirer, 12/11 

“This is going to extremes to worship at the altar of placebo controls.”
— Arthur L. Caplan, PhD, director of Penn’s Center for Bioethics 
“Sham Surgery Is Used To Test Effectiveness of Novel Operations”
The Wall Street Journal, 12/11 

“My bias is that a vaccine has absolutely no downside.”
— Paul A. Offit, MD, associate professor of pediatrics 
and chief of infectious diseases at CHOP
“At Penn, Meningitis Vaccination Encouraged”
The Philadelphia Inquirer, 12/7 

“When my patients offer me gifts that might seem to create an obligation for other patients, or that might improperly influence my judgment, I explain that I do this work because it’s what I love, not because I expect a reward.”
— David Casarett, MD, associate medical director, Wissahickon Hospice 
“Gifts From Patients Create a Quandary” 
The New York Times, 12/15

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NOTHING TO FEAR. . . In the 1980s, a new class of drugs radically changed treatment options for patients with depression. But doctors say an older treatment method still works best for severe, near-suicidal depression: shock therapy. Despite the scary images movies portray, the therapy is done under closely controlled, safe conditions. “[Patients] don’t feel anything,” Martin P. Szuba, MD, assistant professor of psychiatry, told Channel 6’s Action News. “They don’t remember anything. And they don’t have any muscle shaking or jerking.” Aired November 25. 

STUBBORN GERM. . . Researchers at Washington University may have discovered how bacteria in the bladder evade both the body’s defenses and antibiotics, causing recurrent bladder infections. The germs seem to burrow past the organ’s surface cells and dig deep into the bladder’s lining. In fact, what seem to be recurring infections may actually be one infection that has never been cured. Alan J. Wein, MD, chair of urology and professor of surgery, commented on the study in The Globe and Mail. “It certainly sounds logical,” he said. “If the bacteria burrow deep down into the bladder you wouldn’t be able to culture them in urine the way we normally do.” Printed November 24.

DIAGNOSIS: FULL OF BEANS. . . More children than ever are being diagnosed with attention deficit hyperactivity disorder, but a federal panel recently concluded that too little was known about the disorder to say how best to identify and treat it. It is estimated that 3 percent to 5 percent of school-age children have the disorder, and many are taking medications such as Ritalin to control it. The problem is that no laboratory tests or brain scans can confirm a diagnosis of ADHD, and some physicians argue against the idea of it. “Embodied in the current ADHD diagnosis is the assumption that a child not fitting into the classroom has a defective brain,” said William Carey, MD, adjunct clinical professor of pediatrics, in the Philadelphia Inquirer. “What is being called ADHD is not a single problem but a variety of problems being lumped together and called by the same name.” Printed November 19.   

SEEING RED. . . If you’re sitting in the sun and wonder if you’ve overdone it, here’s a quick way to tell if you’ve been burned: Use your finger to poke the area that has had the most exposure. If it blanches, the blood vessels have dilated—a sign of sun damage. “Pressing the skin is a good test for the average person,” said Edward Bondi, MD, professor of dermatology, in Conde Nast Traveler. “It can serve as a warning for those who aren’t as careful as they should be.” Unfortunately, some sun damage may have already occurred by the time your skin appears red. Printed December 1.

DICK, JANE, DICK, JANE. . . Though he’d prefer a global ban on human cloning, Glenn McGee, PhD, assistant professor of bioethics, says it’s not too early to think about how to regulate human cloning technology. Of particular concern is the status of cloned children if reproductive technologies come to be used for such purposes; McGee suggests that family courts, rather than national or local legislatures, should resolve any disputes concerning children born through cloning technology. “Cloning is the most difficult regulatory challenge of the 21st century,” he told the Philadelphia Business Journal. “The United States, the United Kingdom, and virtually every government in the world is struggling to figure out some way to allow science to move forward, protect reproductive freedom, and protect children at the same time.” Printed in the November 20-26 issue. 

BACK IN STYLE. . . An inexpensive, low-tech heart-attack treatment that could be used in hospitals worldwide can dramatically reduce the numbers of fatalities, new research shows. The treatment, which was devised in the 1960s but abandoned because poorly conducted clinical trials led doctors to believe it didn’t work, involves giving a patient a mixture of glucose, insulin, and potassium to nourish heart muscles deprived of oxygen. “The thing that makes it potentially very important is the rather astounding positive beneficial effect it had in reducing death rates after a heart attack,” said Timothy Gardner, MD, chief of cardiothoracic surgery and professor of surgery, in the Los Angeles Times. “When we talk about [clot-busting] agents, we say a 10 percent improvement is really notable. This says we can get up to a 40 percent improvement.” Printed November 24.

MOUTH TO MOUTH . . . Follow the advice found in some diet books and you might be headed for health problems, says Gary Foster, PhD, clinical director of the Weight and Eating Disorders Program and assistant professor of psychiatry. Dr. Atkins’ New Diet Revolution, for example, advocates eating fatty foods and lots of protein and restricting carbohydrates and sugars. The Atkins book assures readers that they can eat omelettes for breakfast, cheeseburgers for lunch, and steak for dinner—and still lose weight. “There’s too much evidence that fat is a risk factor for many serious medical conditions, including heart disease. And too much protein stresses he kidneys,” Foster told Weight Watchers magazine. “Any diet that substitutes high-fat foods for carbohydrates is suspect from a health point of view.” Printed in the November issue. 

CONFLICT OF INTERESTS?. . . . From September 1997 to June 1998, four prescription drugs that had been approved by the FDA were pulled from the market because of safety concerns. The withdrawals have some experts wondering if the FDA is approving medications too rapidly; in the preceding 26 years, only 14 drugs were removed. Two federal advisory committees and outside experts, including Brian Strom, MD, MPH, chair of biostatistics and epidemiology and director of the Center for Clinical Epidemiology and Biostatistics, are calling for the creation of a monitoring system that would be independent of the FDA. “When TWA Flight 800 went down, we sent in the National Transportation Safety Board to investigate, not the FAA, Boeing, and TWA. Yet we put drug safety in the hands of the people who approved the drug and those who market it,” he told Money magazine. Printed December 1.

TAKING COMPLEMENTS. . . Long a group that sought medical information only from physicians, seniors are beginning to embrace alternative and complementary medicine. Local demand by seniors for nontraditional medicine prompted the creation of Holistic Approaches to Health, co-sponsored by Penn’s Institute on Aging and the Ralston Wellness Center. Offered twice a year, the six-week seminars cover such topics as “Aging and Nutritional Supplements,” “Homeopathy and You,” and “Healing With Herbs.” Classes are already oversubscribed, Elizabeth Mackenzie, PhD, research specialist for the Institute on Aging, told The Wall Street Journal. “We are giving consumers the information they need to make good choices,” she said. Printed November 23.

STICK WITH IT. . .  DermaBond, a nontoxic adhesive approved by the FDA this fall for sealing certain wounds, is earning praise from physicians and patients in its first few months on the market. The glue forms a bridge that holds layers of skin in place, giving the wound underneath a chance to heal naturally. It’s particularly popular with young children and their parents because it can often be used in place of stitches. DermaBond saves time and is basically painless, Judd Hollander, MD, associate professor of emergency medicine, told The Philadelphia Inquirer. Hollander was one of the physicians who helped test the product. “Long-term results show it looks just as good as sutures,” he said. Printed November 30.

DAS BLOAT. . . For tips on how to cope with irritable bowel syndrome, the Philadelphia Daily News turned to Robin Rothstein, MD, associate professor of medicine. Rothstein’s first suggestion: Start scrutinizing your diet. Foods containing lactose, the sweetener sorbital, vitamin C, and caffeine all can cause problems with bowel function. Try sticking to a low-fat, high-fiber diet, and experiment with eating six mini-meals a day instead of three big ones that can overwhelm your gastrointestinal tract, she added. Losing weight, getting exercise, and keeping your blood sugar down can help too. Patients with symptoms of irritable bowel should undergo a series of tests to rule out other diseases. “It’s a very common disease that really affects the quality of life,” said Rothstein, “and we don’t have a great remedy.” Printed November 18.  

DEATH ON PRIME TIME. . . Both Jack Kevorkian and CBS have come under fire for the November airing on 60 Minutes of a video showing Kevorkian administering a lethal injection to a man with Lou Gehrig’s disease. Arthur L. Caplan, PhD, director of Penn’s Center for Bioethics, says that Kevorkian is hurting his cause. He pointed out that voters in Kevorkian’s state recently rejected an assisted-suicide referendum. “The people of Michigan already told him ‘no.’ This is exactly what makes him more and more marginal. He’s willing to run roughshod over the dignity of the people he’s supposed to be helping,” Caplan told the New York Daily News. Caplan also said there was no journalistic need for CBS to air the video. “I just think it’s inherently wrong to take someone’s dying and put it on national TV,” he said. Printed November 23.

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