Archive 2001 

Item First Surgery in Gene Therapy: Confronting Alzheimer's.

Item  Americans Are Voting with Their Forks - Is Capitol Hill Listening?

Item Turning to Alternative Medicine

 Item Obesity on  rise

Item Privacy Rules Debated

Item Future trends in CAM usage

Item

Confronting Alzheimer's: First Surgery in Gene Therapy

May, 2001 — On April 5th, physicians at the University of California, San Diego (UCSD) School of Medicine surgically implanted genetically modified tissue into the brain of an Alzheimer's patient. This launches the first phase of an experimental gene therapy protocol for Alzheimer's disease.

The 11-hour procedure was performed at UCSD's John M. and Sally B. Thornton Hospital in La Jolla on a 60-year-old Caucasian woman in the early stages of Alzheimer's disease. The patient is recovering well, and was discharged from the hospital Saturday, April 7th.

A second patient has been accepted for the UCSD clinical trial and is expected to receive the gene implant in about three months. Six additional persons with a confirmed diagnosis of early Alzheimer's disease, who are otherwise healthy, are being sought for this phase of the clinical trial.

This Phase I clinical trial, also called a "safety/toxicity" study, is designed to determine whether the gene-transplantation procedure is safe. The study, led by UCSD neurologist Mark H. Tuszynski, M.D., Ph.D., is the first attempt to use human gene therapy to treat a disease of the nervous system. The researchers will attempt to prevent cell loss in Alzheimer's disease using gene therapy to deliver a natural brain-survival molecule called nerve growth factor (NGF) to the dying cells in the brain.

Background

According to the Alzheimer's Association, one in 10 persons over 65 and nearly half of those over 85 have Alzheimer's disease. This neurodegenerative disorder is characterized by build-up of protein plaque and tangles, leading to loss of function and death of brain cells. Alzheimer's patients suffer progressive loss of mental functions such as memory and learning.

The current patient clinical trial is taking place through the UCSD Alzheimer's Disease Research Center (ADRC), established in 1984 as one of the five original Alzheimer's Disease Centers supported by the National Institute on Aging of the National Institutes of Health. Currently there are 30 ADRCs in the U.S.

This trial is based upon a large body of experiments performed first in rats, then in monkeys, over the last 12 years by Tuszynski, U and Fred Gage Ph.D., who was on the faculty at UCSD before joining The Salk Institute for Biological Studies in 1995 (Gage is President-Elect of the Society for Neuroscience).

Early studies in rats demonstrated the feasibility of NGF therapy. For these studies, the researchers infused NGF via pumps directly into fluid-filled areas of animal brains. Although damaged brain cells were regenerated, the NGF also caused a proliferation of cell growth where it was not intended. To more precisely target NGF to specific brain regions, Tuszynski and Gage utilized a gene therapy method for inserting NGF into cells.

Tuszynski, in collaboration with Gage and Jeffrey Roberts, D.V.M., of the UC Davis Regional Primate Center, continued to demonstrate the feasibility of this gene therapy procedure in primates over the next several years. Skin biopsies from monkeys were modified to produce and secrete NGF. Then, the modified cells were surgically grafted directly into the brain tissue of aged monkeys.

In 1999, the initiation of human trials was approved by the Food and Drug Administration and the protocol was reviewed by the National Institutes of Health Recombinant DNA Advisory Committee (RAC).

The Procedure

The surgical procedure was led by UCSD neurosurgeon Hoi Sang U, M.D., who implanted the tissue in the patient's brain using specially designed surgical tools. The process leading to this first surgery began several months ago. A small sample of the patient's own skin cells was collected in a biopsy procedure, and NGF genes isolated from nervous system tissue were inserted. Over a three-month period the genetically engineered cells were grown in culture in a commercial-grade GMP (Good Manufacturing Practices) facility. As they divided and increased in number, they began producing large quantities of NGF.

Before implantation, the scientific team verified that the genetically engineered cells produced the appropriate amount of NGF, and that no harmful contaminants were present.

In the surgical procedure on April 5th, the patient received five implants of modified cells, targeting a region located at the base of the frontal lobe called the nucleus basalis of Meynert. This area contains cholinergic cells, and undergoes profound degeneration in Alzheimer's disease, which is thought to contribute to the decline of cognitive function.

According to Tuszynski, "NGF gene therapy is not expected to cure Alzheimer's disease, but we hope that it might protect and even restore certain brain cells and alleviate some symptoms, such as short-term memory loss, for a period that could last a few years."

If the protocol is successful, implanted cells could begin to affect brain function in a month or two, but Tuszynski cautions that "it may take several years to test the procedure in a large enough number of patients to determine whether it will be useful therapy."

For more information, go to AlzheimerSupport.com
at: http://www.alzheimersupport.com

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Copyright© 2001 by Computer Information Exchange.  All rights reserved.

Item

Americans Are Voting with Their Forks – Is Capitol Hill Listening?


April 5, 2001 — The subject of food safety continues to fill the halls of Capitol Hill. One quick search of the Internet today brought up these headlines:

• Frankenfoods, Antibiotics, & Mad Cow — America's Food Safety Crisis Intensifies
• Bush Administration Receives Criticism for Rolling Back Regulations
  on Arsenic Levels in Drinking Water
• USA Government Falls Short on Testing for Mad Cow — Is This A Coverup?
• U.S. to Keep Salmonella Testing for School Meat: "Reading, Writing and... Irradiation?"
• etc., etc.

This Wednesday, the USDA announced plans to eliminate salmonella screening for ground beef bound for school lunches. Thursday, the agency backed off.

The announcement that testing will continue was made after Democrats and consumer advocacy groups criticized the proposal as another example of our current administration trying to relax safety standards. "First, it's arsenic in water. Now it's salmonella in school lunches. Where will this end?" asked Sen. Dick Durbin, D-Illinois, Wednesday.

And while consumer groups chalked up a victory, they are well aware of further battles on the horizon. The administration's reversal on salmonella screening disappointed the meat-processing industry, which has long opposed the stricter screening guidelines, which it claims are too expensive to implement and result in an unnecessary waste of meat.

The search for alternatives to costly screening procedures will no doubt go into high gear. Before Bush's reversal, the USDA had initially proposed "indicator testing" for salmonella, which would mean searching for a strain of the e-coli bacteria that's harmless but whose presence can signal the presence of harmful pathogens.

"We definitely think this is for the better," said Janet Reilly, a spokeswoman for the American Meat Institute, an industry group. "It's a much more science-based testing method. Besides, the salmonella testing rule under the Clinton administration was too strict. The standards were so difficult to meet that costs were going way up. School lunch programs couldn't get the meat they needed." She added that schools are supposed to cook ground beef thoroughly, which should kill salmonella. "Pathogen standards, in our view, are not useful in a raw product when it's going to be cooked."

The American School Food Service Program had supported the Bush proposal. "We think they have a stronger basis in science," said Joe Haas, a spokesman for the group, which represents school food service directors and cafeteria workers.

A challenging response came from Carol Tucker Foreman, who oversaw food safety programs at the U.S. Department of Agriculture under President Carter, "Not all school kitchens follow cooking regulations. The concern is not just about beef — but about uncooked foods that could come in contact with raw beef. A worker could touch a contaminated hamburger and then touch the buns or the lettuce or tomato."

Catherine Donnelly, professor of nutrition and food sciences at the University of Vermont, adds to the dialogue: "While the beef industry has legitimate concerns, consumers' concerns also are very real. When you're looking at food testing for schools, you're seeing a group that's particularly susceptible to food-borne illnesses. In this situation, the meat industry really needs to look beyond financial considerations."

At the time of this report, the USDA has offered a solution: irradiation of our meat — zapping it with a sterilizing ray in order to kill any lurking bacteria. But legitimate concerns remain: Will irradiation be used as a panacea for lax standards throughout the meat production process? In other words, will beef processors feel free to toss anything and everything into ground beef — because they know it will be zapped clean at the end of the day? (As a second grader might say: E-e-eew!)

Perhaps the seminal question is: Are most of our politicians more interested in listening to agribusiness and biotech special interests than what consumers have to say? Is our government in denial about the safety of America's food?

Least Capitol Hill forget, keep voting with your forks, everyone!!

Information sources:

U.S. to keep salmonella testing for school meat; April 5, 2001; CNN.COM website at:
http://www.cnn.com/2001/HEALTH/parenting/04/05/school.meat.02/index.html?s=2

Reading, Writing and... Irradiation?; Apr. 05, 2001; TIME.COM website at:
http://www.time.com/time/nation/article/0%2C8599%2C105260%2C00.html

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Copyright© 2001 by Computer Information Exchange.  All rights reserved.

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Turning to Alternative Medicine and Not Telling Their Doctors 

March, 2001 – A study of Long Islanders finds that many Islanders use some form of alternative medicine and are not telling their doctors.

A recent Newsday-Hofstra University poll of 1,056 Long Islanders found that almost one-half of those who use herbal medicine said their doctors did not know they use herbs, and half said they had not done any research before they began using them. Three in 10 herb and/or megavitamin users said they did not know whether their herbs or vitamins could interact unfavorably with other medicines. And those who had informed their doctor of what they are taking are twice as likely to be aware of potential interactions. 

The fact that so many people don't tell their doctors what they're taking — and doctors don't ask — means that doctors are often left not knowing why a patient may be having a problem — or feeling better. Nor do they know whether a drug they are prescribing might interact with the patient's herbs and supplements. 

While the issue of potential side effects and drug interactions is important, the Newsday's poll uncovered ways in which Long Island mirrors or may even be slightly ahead of what is going on nationally with alternative medicine. The findings are as follows: 

1. About 58% of Long Islanders use some form of alternative therapy.

This is higher than findings from two national telephone polls done at Harvard Medical School which are cited as landmark studies on alternative medicine use and served as the model for Newsday’s poll. In the most recent Harvard study, published last November, 42% used at least one of 16 alternative therapies surveyed.

2. Alternative medicine is a growing phenomenon on Long Island.

Although there is a sizable percentage who have been using some alternative treatments for 10 years or more, most are fairly recent users. Two-thirds of herb users began using them within the past 5 years. 58% of those using energy healing, such as magnets, have been using them 2 years or less; and almost half of those using acupuncture have used it less than a year. 

3. Herbal medicine is the most popular alternative treatment.

About 38% of those who use alternative medicine say they have used herbs in the past year. After herbal medicine, chiropractic and relaxation techniques are most used, followed by megavitamins (defined as taking more than a daily multiple vitamin) and massage therapy. By contrast, the most recent Harvard poll found a huge increase in herbal medicine use, but it was not the most widely used treatment. 

4. Alternative treatments is used as a kind of health insurance to prevent illness or to stay healthy.
 
The number of annual visits to doctors is lower among those who use one or two alternative therapies than among those who use none. As one interviewee stated, "People are putting a much higher premium on good health; they expect to be healthy. It used to be that when you were sick, that was it, but I think people find illness unacceptable and are looking for ways to avert being ill. Today we have a whole spectrum of options.”

Dr. Lawrence Scherr, chief medical officer and chief academic officer for the North Shore-Long Island Jewish Health System, said he was not surprised by the percentage using some form of alternative medicine."I don't think it relates to biases against conventional medicine. I think we're dealing with a population that is a lot more sophisticated and concerned over maintaining their health. We're dealing with a select population that says, ‘I want to be better; I want to be healthier.' I don't see it as a wholesale rejection or migration away from mainstream medicine.”

On the other hand, Dr. Samuel Benjamin, head of the Center for Complementary/Alternative Medicine at the State University at Stony Brook, disagrees, in part. "When you have close to 60% of Long Islanders using complementary medicine, we have indeed a completely alternate health system,” he said. NOTE: The poll supports Scherr's contention that Long Islanders use alternative treatments as a kind of health insurance or to keep an existing ailment from getting worse. 

5. Many convey feelings of frustration or ambivalence about their Doctors.

There doesn't appear to be a "wholesale rejection” of mainstream medicine. The poll showed 59% considered doctors the most reliable source of health information (followed by 13% who cited other health professionals). On the other hand, many depicted medical doctors as not supportive or not aware of alternative approaches. And only 17% said they began using alternative treatment on the advice of a medical doctor.

6. Less than half of users in the majority of treatments surveyed said their doctors knew they were using the treatment.

All Long Islanders interviewed read up on treatments in "various magazines.” Half of those polled get much of their initial information about alternative treatments from friends and relatives, not from their doctor. And only 10% of all those polled said they use the Internet to seek information.

Why people don’t tell their doctors 

The Newsday poll has made it clear that there is an apparent disconnect between what people are doing for their health and what they feel comfortable telling their doctors. 

For 8 of the 16 treatments surveyed, less than half of the respondents had told their doctors they were using the treatment. Among those using herbs, 48% had not told their doctors and among those using megavitamins, 36% said their doctors were not aware. 

Dr. Shibani Ray-Mazumder, head of research at Stony Brook's Center for Complementary / Alternative Medicine, said people may not think their "alternative” treatment is so alternative and thus not worth mentioning. Or, rushed in their 15-minute visit with their conventional doctor, they discuss only specific physical symptoms and don't think to bring other aspects associated with their well-being into the exam room. 

"The focus of conventional medicine has been on the illness and not on the patient, so they leave the rest outside the door” — an occurrence she has often seen in her work with cancer patients. “Patients often do not mention certain things because they don't think they are going to be validated.”

At least in some cases, according to interviews, they are right. Here are a few examples from the Newsday's poll:  

·   Robert Pike, 43, a teacher who lives in Jamesport, said he was tired of using traditional medicine (prescription anti-inflammatories which cause stomach problems) and has been going to a chiropractor for back pain for the past year and a half, despite the fact that his doctor has "pooh-poohed” the treatment and "is not supportive.”

·   Orles Lewis of Amityville eats a fresh garlic clove a day and drinks parsley tea to control her high blood pressure to the point that she doesn't have to take her prescription medication, which she said gave her cramps, muscle spasms and made her dizzy. "Last time I went to the doctor, he asked me, ‘Why don't you take your medicine?' I told him I use parsley and garlic, and he didn't act like he cared for that,'” she said. Lewis’ son recommended garlic which studies have found to lower cholesterol.  

·   Martin Durschlag, 49, of East Meadow, tried the exercises his doctor gave    him for the back pain he suffered after a car accident, but said "they didn't help.” Regular visits to the chiropractor, along with massage therapy and acupuncture gave relief from his pain. He said, “I told my medical doctor but he wasn’t too happy with me. He felt I wasn't getting to the source of the problem.” 

·   Karen Varrone, 52, of Holbrook is plagued by chronic neck and back pain she believes is caused by long hours working as medical transcriber. Once a month she goes to a chiropractor, has tried massage therapy and been to a reflexologist.In addition, she takes tai chi and would like to try Reiki therapy. She hasn't used magnets (but she's "not against them”) and is currently exploring acupuncture. As a result, Varrone doesn't see her medical doctor "very often.“ She’s told him about her non-mainstream treatments. In her experience, "He’s pretty open if you don't go overboard.” 

The lure of alternative therapies

From a public health perspective, researchers and health policy makers should be looking at “why” consumers are attracted to alternative therapies. 

Indeed, the Newsday's poll found that most users aren't spending huge amounts on alternative medicine. Most people spend $40 or less a month out of pocket on the five most expensive treatments: lifestyle diet (i.e., macrobiotics and  vegetarianism), commercial diet (i.e., Weight Watchers), chiropractic, acupuncture and massage therapy. The typical megavitamin user spends $20 a month on vitamins; while the typical herb user spends $18 for herbs monthly. And Interviewees said they paid no money for half of the 16 alternative therapies surveyed. 

But, for many, saving money is not the only lure. Many Long Islanders sited alternative therapies as giving people more options, keeping them out of the doctor's office, avoiding side effects of prescription drugs, and, potentially at least, giving them more ultimate control over their health. 

Regardless of each person’s reason, it does appear that alternative therapies play an important role in health care on Long Island. As one interviewee said, "It's not going to go away. It's not like the Hula Hoop.” 

 
Information source: Newsday, Inc.

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Copyright© 2001 by Computer Information Exchange.  All rights reserved.

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Obesity on the rise among infants and toddlers

Feb. ’01 - Children younger than 4 years of age are not immune to the epidemic of obesity that has swept the modern world, researchers report.

A new study chronicles a sharp rise in the number of infants and toddlers who were classified as obese between 1989 and 1998. The results, published in the February 10th issue of the British Medical Journal, underscore the need to encourage even very young children to be physically active and follow a healthy diet, according to Dr. Peter Bundred, from the University of Liverpool in the UK, and colleagues.

Overweight children are more likely than their leaner peers to grow into obese adults, and excess weight is a major risk factor for heart disease, type 2 diabetes and death, the authors note.

The study concluded low levels of long-term breastfeeding and the hectic pace of modern life are to blame. According to the authors, "The majority of families (in the UK) have both parents working and it is easier to entertain the toddler with a sweet drink in front of the TV than to play with them in the evening. In fact, children are losing the skills to play."

Interventions that encourage physical activity and weight loss should be targeted to children younger than 4 years, the authors suggest. The study findings could be used to develop national programs to prevent and treat obesity in children, the report indicates.

Information source: British Medical Journal 2001;322:326-328.

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Health Industry & Consumers Debate Privacy Rules

January, 2001 - Clinton administration regulations issued in December to protect the confidentiality of medical records may have been called "final," but the debate is far from over. Groups representing patients and the health care industry appeared this Thursday before the Senate Health, Education, Labor and Pensions Committee — calling for changes.

Earlier in the week, 39 industry groups wrote to Health and Human Services Secretary Tommy Thompson, urging him to delay the February 26th effective date of the rules. Representatives of several of those groups told the committee that, as written, the rules are unworkable.

Opponents argued "not only are the rules likely to be more expensive than many entities will be able to bear — and likely to cost far more than the $17.6 billion estimated by HHS — but the final version of the rule includes a new requirement for individual consent for treatment, payment, and other routine uses of information that could prove problematic."

Health care industry officials expressed concern about allowing stronger state privacy laws to remain in place. "In cases where patients live in one state, work in another, and receive care in a third," asked Robert Heird of Anthem Blue Cross and Blue Shield, "is it governed by (the state law) where the policy is written, where the patient lives, or where the care is provided?"

In support of the patient, "the American Psychiatric Association is particularly concerned about the need for sensitivity with psychiatric patients' names," said testimony submitted by the APA. "Commercial fundraisers should not be allowed to take advantage of patients, especially those with mental illness."

Patient advocates, who strongly support the new rules, want them strengthened even further. They asked the committee to act to create a "private right of action" to allow those whose information is wrongly disclosed to sue for damages, and to close what some call a "loophole" in the regulations allowing the use of personal information for marketing and fundraising.

Information source: Reuters Health; Jan. 2001.

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Long-Term Trends In CAM Usage

Sept., 2001 — CAMBRIDGE, MA — The demand for complementary and alternative medical therapies — including chiropractic, acupuncture and herbal medicines — will continue to grow, according to a study conducted by researchers at Harvard Medical School.

Although recent research has shown that many people in the United States use complementary and alternative medical (CAM) therapies, little is known about time trends in use. Previously reported analyses of these data (1997) showed that more than one third of the U.S. population was using CAM therapy.

Recent analyses of lifetime use and age at onset showed that 67.6% of respondents had used at least one CAM therapy in their lifetime. Researchers also detected an increasing trend corresponding to age among respondents: Approximately 3 of every 10 "pre–baby boom" respondents reported experience with CAM therapies; that number grew to 5 of 10 in the baby boom generation; with 7 of 10 in the "post–baby boom" reporting use of some type of CAM therapy by age 33 years.

Of respondents who ever used a CAM therapy, nearly half continued to use many years later. A wide range of individual CAM therapies increased in use over time, and the growth was similar across all major sociodemographic sectors of the study sample.

Conclusions: Use of CAM therapies by a large proportion of the study sample is the result of a secular trend that began at least a half century ago. This trend suggests a continuing demand for CAM therapies that will affect health care delivery for the foreseeable future.

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Copyright© 2001 by Computer Information Exchange.  All rights reserved.

Information source:
Annals of Internal Medicine; 2001;135:262-268.