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The Fibromyalgia Community Newsletter # 11 Friday, 02/15/2002
http://www.fibrom-l.org or http://www.fmscommunity.org
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This week's News Summary:

1) The Manual Tender Point Survey
2) Article: Eating to Deal with Stress May Pack on Pounds
3) Article: Chronic pain is not just pain that lasts a long time...
4) Research: A Reduced Functionality of Gi Proteins as a Possible Cause of Fibromyalgia
5) Resource: Discount Prescription Medicine Card Offered by Three Pharmaceutical Companies
6) Research: Treatment of chronic fatigue with neurofeedback and self-hypnosis
7) Article: Say 'No' to Responsibility Overload
8) Article: Anakinra Appears A Promising Therapy For Rheumatoid Arthritis
9) Announcement: Success Stories
10) Article: Understanding Dietary Fibre
11) Article: Who is Protecting the Public Health? Can We Trust the Regulators?
12) Article: Gut Thoughts
13) Research: Relationships Between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry
14) Website: How Stuff Works
15) Research: Tegaserod Benefits Some Women with Irritable Bowel
16) Press Release: CAA Releases CFIDS Public Service Announcement
17) Results of our latest Poll

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Note: Full Stories on some articles are available via web links
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1) The Manual Tender Point Survey

by David Sinclair, MD, Terence W Starz, MD, Dennis C Turk, PhD (Jointly sponsored with the University of Pittsburgh School of Medicine Center For Continuing Education in the Health Sciences.)

Introduction Widespread musculoskeletal pain has long plagued humankind. It made its appearance in past epochs as lumbago, muscular rheumatism, and fibrositis. Most recently the condition has been labeled as fibromyalgia (FM).

Although etiology and pathophysiology of FM are widely debated, the clinical entity described as FM is estimated to affect from three to six million people in the United States. Historically, there has been great variability in the criteria used for diagnosing FM. The American College of Rheumatology (ACR) conducted a multicenter study published in 1990 that specified two primary criteria that characterized FM: (1) three or more months of widespread pain defined as pain present above and below the waist on the right and left side of the body and along the midline and (2) report of pain at a minimum of 11/18 specified locations (tender points - TPs) throughout the body when palpated with 4 kilograms of digital pressure.
These two criteria were selected from a number of variables examined as they were shown to reliably discriminate FM from other musculoskeletal disorders in the multicenter study.

TPs are widely distributed throughout the musculoskeletal system. They are typically located in the muscle bodies, over tendinous insertions and at bony prominences. The anatomic and physiological mechanisms accounting for the presence of TPs have received great attention but explanation for their origin remains unclear.

A number of factors may influence the sensitivity of TPs during an examination: (1) the amount of force applied at the survey site, (2) the number of times (single versus repeated) and method (finger pad, dolorimeter) by which the force is applied, (3) the patient's position, which affects muscle tone and survey site localization. The sequence of site examination may influence the patient's response based on the anchoring effect of sensations experienced at prior survey sites. A standardized examination procedure enhances the reliability of survey site reporting, interobserver reproducibility, the comparability of research studies and the direction of treatment modalities.

The Manual Tender Point Survey (MTPS) outlined in this document describes a technique requiring approximately 5-10 minutes to perform. It is based on the 1990 American College of Rheumatology tender point protocol for FM.
This guide will (1) describe the pressure application technique, (2) discuss the precise identification of survey sites, and (3) review the complete Manual Tender Point Survey examination including the standardized examination procedure and patient instructions.

Read the complete article at http://fmaware.org/doctor/tenderpt.htm <a href="http://fmaware.org/doctor/tenderpt.htm">Read it here</a>


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2) Eating to Deal with Stress May Pack on Pounds

NEW YORK (Reuters Health) - For those who reach for a cookie when times get tough, stress may take a toll on the waistline, a Finnish study suggests.

Researchers found that for people who said stress often drove them to eat, the comfort food of choice tended to be greasy, salty or sweet. Not surprisingly, such "stress-driven" eaters, particularly women, weighed more on average.

Dr. Jaana Laitinen, of the Oulu Regional Institute of Occupational Health, and colleagues report the findings in the current issue of Preventive Medicine.

The researchers looked at 5,150 individuals at four points in their lives--birth and ages 1, 14 and 31. At age 31, the participants' body mass index, eating habits and methods of coping with stress were studied. Those who said they often or sometimes tried to make themselves feel better by eating and drinking were designated as stress-driven eaters.

Laitinen's team found that these individuals were more likely than others to frequently eat pizza, hamburgers, sausages and chocolate. They also drank more alcohol, on average, according to the report.

For both men and women, body mass index--a measure of weight, taking height into account--was higher among stress-driven eaters than others. For women, obesity was associated with eating to cope with stress.

Men were more likely to eat in the face of stress if they were single, divorced or frequently unemployed. The tendency was also seen in men with academic degrees--which is surprising, the researchers note, since higher education is often linked to lower rates of obesity. They speculate that the young men in this study may be more susceptible to stress caused by on-the-job demands compared with older, more experienced workers.

Among women, those who felt a lack of emotional support in their lives had a greater tendency to eat to cope with stress, the report indicates.

The researchers conclude that efforts to prevent or treat obesity should address the ways in which people cope with stress.

"Programs aimed at preventing and treating obesity," they write, "should cover the way in which people deal with emotions, ways of achieving greater emotional support, and strategies for handling stress caused by unemployment or work."

SOURCE: Preventive Medicine 2002;34:29-39.

Read the complete article at http://story.news.yahoo.com/news?tmpl=story&u=/nm/20020204/hl_nm/fat_1 <a href="http://story.news.yahoo.com/news?tmpl=story&u=/nm/20020204/hl_nm/fat_1 ">Read it here</a>


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3) Chronic pain is not just pain that lasts a long time...
by Pat Oreilly

I am still amazed when I hear people talking about pain and realize that even when they have lived with pain for some time they have no understanding about what the term "chronic pain" really means. Chronic Pain is not just pain that has lasted a long time. Chronic pain is a complex condition that when left untreated can cause serious physical and emotional damage to the person that has unwillingly become the host for this life shattering villain. Let's take a look at pain.

Acute pain is a signal from the body to the brain that there has been an injury and some action is necessary to stop the pain or keep it from getting worse. It is the message that causes us to pull away from the source of the pain, or to protect our self from further damage by protecting the area quickly. This is the most common type of pain. It is the pain we learn about in biology and it is usually treated successfully. All doctors understand acute pain, it is unpleasant but usually responds well to treatment. .

Chronic pain is a different animal entirely. Chronic pain means that the pain has remained after the acute phase has healed, or should have healed.
This is an important distinction because chronic pain is complicated, difficult to treat, and left untreated it causes even further damage in the body. A chronic pain condition means that instead of the body sending a message to the brain about injury, the brain is generating the pain message on its own and sending it to the body. The severity of chronic pain has no relationship to the severity of the incident that caused it. The injury may have been a minor one yet the pain is so intense that the person experiencing it cannot bear it. In some cases there never was an illness or injury, the pain message center became dysfunctional on its own.

In addition, in a chronic pain condition the same nerves that carry the physical pain message also carries psychic pain messages which are anger, depression, anxiety and others. Since both messages travel to the body along the same neuropathways they become intertwined and produce a combination message that tries to tell the body there is pain, both physical and emotional. For treatment to be effective both psychic and physical must be addressed. Furthermore, each individual has a different percentage of physical and psychic, making the generic method of pain management worthless for many.

And that is just the beginning of the dilemma. Once pain messages are generated and sent to the body, the pain itself begins to change the nervous system, hormonal system and many other systems in the body. Once again, these changes are unique to each patient therefore treatment must encompass many factors in the right amounts and strengths. Many of these changes are permanent. Once they happen there is no going back.

Also, it is common for people to experience both chronic pain and acute pain at the same time. Conditions such as Arthritis, autoimmune disease, back injuries are all examples of both acute and chronic pain in one person. Many doctors only treat the acute pain, which is the easiest to treat, and leave the chronic pain. This is dangerous because it is the chronic pain that causes the changes in the body.

Treating chronic pain successfully means that the person must find a certain percentage of relief from many modalities. Perhaps the person can experience 40% relief from medication, 20% relief from exercise, 10% from relaxation exercises and so on. Finding the right combination can be very tricky but the option of not finding relief where one can means that it is likely the pain or the changes will get worse and the person will end up suffering even more. This not a condition that responds to the grin-and-bear-it method of pain control. Do that and eventually you may be able to do nothing at all.

Pain has changed your life and the only way to survive is to make lifestyle changes that can fight the damage pain. By learning all you can, making permanent changes with those therapies that you find that do help and keeping the best attitude possible one can still win the battle over pain.

Remember, chronic pain is not just pain that lasts too long. It is a separate condition that is complicated, has a mind of its own and wants to destroy you. Fight back, your life is at stake.

http://www.painmanagementtheory.homestead.com./pain.html <a href="http://www.painmanagementtheory.homestead.com./pain.html">Read it here</a>


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4) A Reduced Functionality of Gi Proteins as a Possible Cause of Fibromyalgia

NICOLETTA GALEOTTI, CARLA GHELARDINI, MASSIMO ZOPPI, ENRICO DEL BENE, LAURA RAIMONDI, ELISABETTA BENEFORTI, and ALESSANDRO BARTOLINI

ABSTRACT.

Objective. The etiopathogenesis of fibromyalgia (FM), a syndrome characterized by widespread pain and hyperalgesia, is still unknown. Since the involvement of Gi proteins in the modulation of pain perception has been widely established, the aim of the present study was to determine whether an altered functionality of the Gi proteins occurred in patients with FM.

Methods. Patients with FM and other painful diseases such as neuropathic pain, rheumatoid arthritis (RA), and osteoarthritis, used as reference painful pathologies, were included in the study. The functionality, evaluated as capability to inhibit forskolin-stimulated adenylyl cyclase activity, and the level of expression of Gi proteins were investigated in peripheral blood lymphocytes.

Results. Patients with FM showed a hypofunctionality of the Gi protein system. In contrast, unaltered Gi protein functionality was observed in patients with neuropathic pain, RA, and osteoarthritis. Patients with FM also showed basal cAMP levels higher than controls. The reduced activity of Gi proteins seems to be unrelated to a reduction of protein levels since only a slight reduction (about 20-30%) of the Gi3a subunit was observed.

Conclusions: Gi protein hypofunctionality is the first biochemical alteration observed in FM that could be involved in the pathogenesis of this syndrome. In the complete absence of laboratory diagnostic tests, the determination of an increase in cAMP basal levels in lymphocytes, together with the assessment of a Gi protein hypofunctionality after adenylyl cyclase stimulation, may lead to the biochemical identification of patients with FM. (J Rheumatol 2001;28:2298-304)


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5) Discount Prescription Medicine Card Offered by Three Pharmaceutical Companies

Three pharmaceutical companies - Pfizer, Novartis, and GlaxoSmithKline - now offer a discount card to Medicare patients who can't afford their medicines. Each program is different and unique.

Here are the URLs for the sites for these three companies.

http://www.pfizer.com/pfizerinc/about/sharecard/sharecard.html <a href="http://www.pfizer.com/pfizerinc/about/sharecard/sharecard.html">Read it here</a>


http://www.novartis.com/carecard/ <a href="http://www.novartis.com/carecard/">Read it here</a>

http://www.gsk.com/press_archive/press_10032001.htm <a href="http://www.gsk.com/press_archive/press_10032001.htm">Read it here</a>


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6) Treatment of chronic fatigue with neurofeedback and self-hypnosis.

Hammond DC.

Department of Physical Medicine & Rehabilitation, University of Utah School of Medicine, Salt Lake City, UT, USA.

A 21 year old patient reported a relatively rapid onset of serious chronic fatigue syndrome (CFS), with her worst symptoms being cognitive impairments. Congruent with research on rapid onset CFS, she had no psychiatric history and specialized testing did not suggest that somatization was likely. Neuroimaging and EEG research has documented brain dysfunction in cases of CFS. Therefore, a quantitative EEG was done, comparing her to a normative data base. This revealed excessive left frontal theta brainwave activity in an area previously implicated in SPECT research. Therefore, a novel treatment approach was utilized consisting of a combination of EEG neurofeedback and self-hypnosis training, both of which seemed very beneficial. She experienced considerable improvement in fatigue, vigor, and confusion as measured pre-post with the Profile of Mood States and through collaborative interviews with both parents. Most of the changes were maintained at 5, 7, and 9 month follow-up testing.

NeuroRehabilitation 2001;16(4):295-300 PMID: 11790917 [PubMed - in process]

www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?form=6&db=m&uid=11790917 <a href="http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?form=6&db=m&uid=11
790917">Read it here</a>


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7) Say 'No' to Responsibility Overload

An interesting fact is that many "stressed out" people are not poor stress managers- they are simply overloaded with commitments and responsibilities.
In this case stress arises from an overbooked schedule or a greater number of responsibilities than one can reasonably handle.

Perhaps you recognize the signs of "responsibility overload" in your own schedule. Despite a major upcoming deadline and long hours, you find yourself agreeing to organize the office holiday party. Although your afternoons are already packed, you end up coaching your daughter's soccer team. You're president of your tenants' association because you did it last year and hate to let your neighbors down. Most of us know the feeling of wondering why we ever agreed to take on yet one more responsibility. Even school-age children can experience stress from an overloaded extracurricular schedule.

Finding things to eliminate (and to decline, in the future) in a too-busy schedule can help you not only to reduce stress, but also provides you with more time for yourself and more energy to deal with your remaining commitments. Look closely at how you spend your non-working, non-sleeping hours. Examine your social, family, and community commitments and ask yourself: Is this a true obligation for me? It's up to you to decide which activities you feel are most important and cannot be missed. Do I want to do this? Will this activity or event bring me joy? Will my participation bring joy or happiness to someone important to me? Looking at your schedule with a critical eye will help you to target areas in which you can make cutbacks.

Many people report that they assume too many responsibilities because they do not want to be perceived as lazy or unhelpful, or because they do not want to be seen as letting others down. For many, learning to say no to others' requests is the most difficult time management task. Although it seems like a simple step, a large number of people admit that they often agree to requests because they have difficulty refusing them. In this case it is helpful to actually rehearse how you will react next time you are asked to take on a responsibility you don't want to accept. Practice the following responses if you need help saying "no":

"I'm not taking on any more charity/volunteer/community/ projects right now."
"Sorry, I'm just not able to plan that far ahead now."
"I've got so much on that I'm not scheduling anything new right now."
"We're having a quiet holiday with just the family this year."
"I really don't feel that I'd be able to provide the required commitment level to do justice to the project."

Remember, you do not owe others an explanation or defense of your choices.
Deliver your answer with a friendly smile and refuse to be drawn into a debate or discussion. For more practical tips on saying 'no,' psychologist Dr. Linda D. Tillman writes about "The Power of Saying 'No'" and gives advice for those "people pleasers" who readily agree to any request.

As with all changes and improvements, learning to free yourself from overloaded and unwanted responsibilities is a skill you can improve with time, leading ultimately to a more balanced life and better stress management.

http://stress.about.com/library/weekly/aa100700a.htm <a href="http://stress.about.com/library/weekly/aa100700a.htm">Read it here</a>


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8) Anakinra Appears A Promising Therapy For Rheumatoid Arthritis By Veronica Rose

Anakinra (Kineret) appears effective in treatment for rheumatoid arthritis, according to researchers.

The drug has a totally different mechanism of action to any other treatments available for these patients he says.

The therapy, which has a totally different mechanism of action from any other treatment available, is designed for moderate to severe active rheumatoid arthritis. It blocks interleukin -1 and is recommended for patients with RA whose previous treatments have proved unsuccessful.

Dr Michael Schiff, director of the clinical research unit at Denver Arthritis Clinic in the United States, said that Kineret received FDA approval following four randomized, double-blinded, placebo-controlled clinical trials. Participants included 2932 patients, aged 18 years or more, with active rheumatoid arthritis. The therapy was not given to patients who were taking the tumour necrosis factor blocking agents, etanercept and infliximab.

The first two trials used standard 100-mg/daily, self-administered injections of anakinra combined with a placebo and methotrexate (MTX). The third trial included a dose-ranging study during which patients were randomized to receive placebo or subcutaneous anakinra injections composed of either 0.04mg/kg, 0.1 mg/kg 1.0mg/kg or 2.0mg/kg daily. The last study was an efficacy test to establish the safety of the treatment when combined with other disease modifying antirheumatic drugs which include sulfasalazine, hydroxychloroquine, gold, penicillamine, leflunomide and azathioprine.

Six months later, 38 percent of patients receiving anakinra suffered less pain and swelling by comparison with 22 percent of those given placebos.
There was a 20 percent improvement in the symptoms among patients who were treated with combined anakinra and MTX by comparison with those receiving MTX and placebo. A 20 percent improvement was also revealed in the number of swollen and tender joints in patients who received anakinra alone.

Side effects were only minor, said Dr Schiff. The most common (50-70 percent of patients) was reaction at the injection site, something found with many injections of protein. It occurs early and disappears, not a proving to be a big problem. This has not caused patients to discontinue Kineret, especially if they are experiencing a good clinical response. There was a 2 percent risk of serious infection in patients during clinical trials.

Administering higher doses did not improve the response rate. Researchers considered that anakinra should be discontinued in the event of serious infection. Once the infection has disappeared, the patients can resume the treatment.

The drug's future was potentially good, and as the treatment continues, anakinra could decelerate degenerative progression observable by x-ray and also slow down destructive bone changes.

Orthopedics Today January 2002. "New rheumatoid arthritis treatment blocks interleukin-1 protein"

http://www.docguide.com/news/content.nsf/news/8525697700573E1885256B480076A7
08?OpenDocument&id=A0C15EBDF4D14E648525691A00552163&c=&count=10 <a href="http://www.docguide.com/news/content.nsf/news/8525697700573E1885256B48
0076A708?OpenDocument&i d=A0C15EBDF4D14E648525691A00552163&c=&count=10">Read it here</a>


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9) Success Stories

Bruce Campbell describes his use of self-help to recover from CFIDS in the new feature article at the CFIDS/Fibromyalgia Self-Help website:
http://CFIDSselfhelp.org.

The article is the fifth in our new series "Success Stories," personal accounts of coping and recovery. Also, review the complete list of bi-weekly features in the Articles Archive, which is divided into four sections: Ten Keys to Coping and Recovery, Success Stories, coping strategies, and articles about our self-help program.

Jan Wolski CFIDS/Fibromyalgia Self-Help Program

http://CFIDSselfhelp.org <a href="http://CFIDSselfhelp.org">Read it here</a>


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10) Understanding Dietary Fibre

Leo Galland M.D., F.A.C.N.
Director, Foundation for Integrated Medicine

(Author of Power Healing: Use The New Integrated Medicine to Heal Yourself, Random House, 1997)

Fibre is the term that describes remnants of plant cells that are resistant to human digestion. The usual sources are vegetables, cereals, bread, nuts, seeds and fruits. Although medical researchers have been recommending high fibre diets for about twenty years, and sales of metamucil and other bulk laxatives have gone up, there has been no significant increase in fibre consumption from food and the fibre intake of Americans is far below recommended levels. This is unfortunate, because the fibre found in food is far more complex than the purified powders sold in drug stores.
There are many different chemical types of fibre, but the most important distinction is between soluble and insoluble fibre. Soluble fibre dissolves in water, forming a thick gel. Fruit pectin, for example, is a highly solube fibre. Psyllium seed, the commonest source of bulk laxatives, contains fibre that is moderately solube. Wheat bran consists of relatively insoluble fibre that is most readily evident as "roughage". Although all fibre adds bulk to bowel movements, the chemical effects of the different types of fibre can be opposite.

Soluble fibre feeds the intestinal bacteria, which ferment it to produce chemicals called short chain fatty acids (SCFAs). SCFAs have a number of positive effects on the body: they nourish the cells of the large intestine, stimulating healing and reducing the development of cancer. When absorbed from the intestine, they travel to the liver and decrease the liver's production of cholesterol, lowering blood cholesterol levels. Oat bran, for example, contains fibres of moderate solubility; eating oat bran can lower cholesterol levels. Within the intestinal canal, SCFAs inhibit the growth of yeasts and disease-causing bacteria. The effects of soluble fibre are not always beneficial, however. Feeding high levels of soluble fibre supplements like guar gum encourages an overgrowth of the normal intestinal bacteria which deprives the body of vitamin B12 and produces an increase in the concentration of bacterial toxins. Excessive consumption of soluble fibre from supplements can may create changes in the intestinal milieu that actually enhance the development of stomach or bowel cancer.

Insoluble fibre does not feed bacteria well and is not readily fermented to SCFAs. Eating wheat bran, which is largely insoluble fibre, has no effect on blood cholesterol levels. Insoluble fibre inactivates intestinal toxins, however, and high intake of insoluble fibre is associated with a decreased risk of colon and breast cancer. Supplements of insoluble fibre as wheat bran or pure cellulose appear to decrease the risk of bowel cancer.
Insoluble fibres also inhibit the ability of disease-causing bacteria and parasites to attach themselves to the intestinal wall. Insoluble fibre plays an important role in preventing excess intestinal permeability.

It should be obvious that humans need a mixture of soluble and insoluble fibres in the diet and that food, not supplements, is the best source.
Eating high fibre foods protects against the development of the major degenerative diseases of the modern world--heart disease and cancer--increases longevity and protects against the development of parasitic infection. The best sources of mixed fibres are unrefined cereal grains (oats, brown rice, whole wheat), peas, beans and squash. Among fruits, one gets the most fibre per serving from apples and berries.

If you become constipated when increasing dietary fibre, you may need more fluid. Drink eight glasses of liquid a day, between meals, not with meals.


http://healthy.net/asp/templates/column.asp?PageType=Column&id=66 <a href="http://healthy.net/asp/templates/column.asp?PageType=Column&id=66">Rea d it here</a>


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11) Who is Protecting the Public Health? Can We Trust the Regulators?
By Meryl Nass, MD

Twenty years ago, as a newly qualified doctor, I spent a lot of time in the library reading review articles about my patients' diseases.

Twenty years later, my time in the library is too often spent reading about problems and conflicts of interest within the medical establishment. Here are a few examples:

Industry-funded research results in a much higher proportion of studies showing positive results for new drugs, compared to publicly-funded research.

Flawed regulatory oversight resulted in licensing, then withdrawal, of many dangerous drugs in the past five years.

Established protections for human subjects in medical research, which did not prevent the deaths of several subjects in high-profile cases recently, are being undermined.

Can Medical Research Findings Be Trusted?

The education of my later years has produced a doctor who is forced to fall back too often on anecdotal evidence and personal experience, rather than trusting the "last word" of the experts and our top medical journals.
Despite all the information now at our fingertips, this loss of faith in the quality of the available data pushes the practice of medicine backward, not forward. Report after report confirms that I would be foolish not to have serious misgivings regarding the results of clinical trials, trepidation towards newly-licensed drugs, and a lack of trust in the so-called giants of my profession.

Too many of these giants would enforce the practice of "evidence-based medicine" and "clinical guidelines" on the rest of us: but the problem is, who paid for the evidence and the guidelines?

This week's Journal of the American Medical Association reported that a full nine out of ten doctors on committees that develop clinical guidelines had financial ties to the industry whose products they recommend. Six of ten doctors had financial ties to companies whose drugs were considered in the guidelines they wrote. And pharmaceutical companies paid for the development of 25 per cent of the guidelines.

If medical research is done properly, with good controls and enough subjects for statistical validity, why do so many studies yield answers that are in direct opposition to each other?

It was widely reported this week that mammograms do not save lives; the studies that had claimed they did, were fatally flawed when they were (finally) carefully examined.

There is no question that use of mammograms leads to earlier diagnosis of breast cancer than not using mammograms. But this does not result in improved life expectancy. Does it mean that we should stop seeking early detection for breast cancer - that breast cancer is in some way different from all other cancers?

Are we even asking the right question? Is the problem the mammogram, or is the problem that aggressive treatment of breast cancer could actually decrease life expectancy in many cases, so that overall there is no treatment benefit in this disease? I don't know the answer. Has anybody performed solid research to answer the question?

Because there exists a multi-billion dollar establishment that deals with breast cancer in a fairly monolithic way, one is limited as to what questions are allowed to be asked. (You can ask away, but who will fund your research?) Research funded by the federal government is generally constrained to stay within the existing boundaries of disease management, despite its public funding. It will often mirror corporate-sponsored research.

When you don't ask the right questions in clinical research, you can obtain answers that result in worse patient care. Corporate sponsors of research are not going to spend millions for a trial that could produce an answer in conflict with their goals, if they can avoid it. (Unfortunately, their "wrong" answer could have important clinical implications, but since the industry has often tried to prevent publication of negative results, we may never learn of these research findings.)

Since the drug manufacturer's primary responsibility, whether funding research or in other matters, is to the bottom line, we should not expect any other behavior.

However, the role of federal agencies is oversight and regulation. Their job is to protect all those with a stake in clinical research: the researchers, the subjects, and the public, who may someday need the treatment in question. Federal agencies should simply acknowledge that pharmaceutical companies have interests that will not align with those of patients and physicians, and regulate them accordingly.

Loosening Institutional Protections

Over the last decade there has been a shift backward by regulatory agencies charged with protecting the public health. Although the shift at FDA has been blamed on the 1992 Prescription Drug User Fee charged to the manufacturer to review new drugs and to expedite drug approval, the problems seem to me to be much more profound. Years ago, a new treatment had to be proven safe before it could be used; during the past 8-10 years, unless there was significant evidence of danger, new drugs were assumed to be safe.
In a 1998 survey, FDA's medical officers themselves reported that standards for drug approval had declined.

Richard Horton, editor of The Lancet, last May described the FDA's process for the re-licensing of a drug that had earlier been taken off the market.
He explained, step by step, how the FDA had a "two track process, one official and transparent, one unofficial and covert." FDA controlled the composition of its advisory committee, and its agenda, so the committee would not overturn the agreement already made between senior FDA staff and industry executives. Clearly, there is a big problem at FDA.

A move to weaken human subject protections in clinical research has occurred parallel to this weakening of drug oversight.

CDC recently sponsored a trial of post-exposure anthrax vaccine use. FDA approved the trial. The study's consent form acknowledged that preliminary data showed anthrax vaccine could cause birth defects. Since for the preceding two months antibiotic treatment had been 100 per cent successful at preventing anthrax in those exposed, it was not at all obvious that vaccination offered any additional benefit. Yet pregnant women were invited to enroll as subjects.

Isn't it unethical to offer a vaccine to pregnant women that might cause birth defects, and one that was not necessary? But that wasn't the end of it. FDA just approved the license for anthrax vaccine, and approved a new anthrax vaccine label, which became public five weeks after the CDC study began. The new label clearly states that no animal experiments have ever been performed to determine the vaccine's effect on pregnancy.

What logic led both CDC and FDA to experiment on human fetuses in the complete absence of animal fertility data? How could pregnant females be used as guinea pigs, before any guinea pigs or mice were studied? These agencies have lost sight of their mandate to protect the Public Health.
Their lack of ethics might have been influenced by the Defense Department's contribution to their budgets, which amounted to $2.5 billion last year for CDC.

Additional moves are afoot to weaken the protections for children in clinical research. Children cannot provide informed consent; therefore, how can you ethically use them as experimental subjects? Until now, there had to be a very good reason to use a child. For example, the child had to have a disease that would benefit from a new treatment.

The Jesse Gelsinger case, in which a teenager died from participation in a gene therapy experiment from which no personal benefit was expected, demonstrated that fully informed consent is often missing in clinical trials. Informed consent is presented to potential participants by the researcher, who has a vested interest in signing up subjects. Its oversight by institutional review boards tends to be cursory. In the Gelsinger case, the principal investigator, along with the University of Pennsylvania, had a large financial stake in the outcome of the experiment.

Perhaps half the drugs used in children have never been licensed for pediatric use. They are prescribed "off-label" by clinicians. Is this a problem? Not for most drugs, such as antibiotics, which have demonstrated safety and efficacy over many millions of doses. Both patients and doctors are perfectly satisfied using such drugs in the pediatric population, on or off label.

But in the case of other drugs, such as psychotropic medications, many doctors are loathe to prescribe for children without adequate pediatric testing. Drugs that are given indefinitely are better moneymakers than antibiotics, which are only used for 10 days at a time. So expanding approvals for chronic drug use into the pediatric age group could yield handsome rewards.

Perhaps as a result, the rules for using children in clinical research are being undermined. No longer would a child need to clearly demonstrate potential benefit from a new treatment before being enrolled in a trial; proposed rules would allow a child who is simply "at risk of" the condition to be used as a subject. But most of us are "at risk of" most diseases.

Furthermore, new consent forms have been developed that allow adolescents to provide a modicum of "informed consent." (They were used in CDC's recent anthrax vaccine trial.) Treating a child like a small adult for the purpose of obtaining research subjects weakens the authority of the parent to protect his child. When it is nearly impossible for an adult to understand the legal implications of the consent form he signs, what must it be like for a child?

When a family is paid for a child's participation in research, the parent joins the researcher in assuming a conflict of interest.

Unless there is a clear potential benefit to the child, let's keep our children out of the laboratory.

Employing Bioterrorism Fears to Weaken Regulatory Oversight

You cannot compel people to become experimental subjects: that is the legacy of Nuremberg. If a drug or vaccine is not fully-licensed, it cannot be forced on anyone.

But it is desirable to have drugs ready to counteract a chemical or biological attack If the illnesses anticipated from an attack do not occur naturally in the population, one cannot test the new drugs for effectiveness. It would be unethical to expose people to a chemical or disease just to test whether the new drug is truly protective.

That results in a conundrum: if you have to prove effectiveness in human trials to license a drug, but you can't do the trial, then you can't license the drug. If the drug is not licensed, it can be used with informed consent, but you cannot force people to take it.

The Defense Department was not satisfied with that. There is no provision for informed consent on the battlefield, and a soldier who refuses an experimental treatment could endanger the lives of his colleagues, so they said.

Presidential Order 13139 was issued by President Clinton to deal with this situation. It allowed the President, in consultation with the Secretary of Defense and the FDA Commissioner, to require that troops take experimental drugs or vaccines in special circumstances.

That should have been adequate to take care of the situation, but the federal authorities were still not satisfied. The National Research Council (of the National Academies of Science) was contracted to report on protecting troops from bioterroism.

"How can we ensure safety of troops if we have to go through an onerous two or five years of certification [for new drug approval]?" asked Robert Love, the study director.

His June 2001 report recommended that the Army seek exemptions from some regulatory approval processes to speed up the development of new medical treatments.

CDC did its part by contracting with Laurence Gostin, a law professor at Georgetown University and professor of public health at Johns Hopkins University, to create a "Model Law" that the states would be encouraged to use. It would give state officials the authority to involuntarily quarantine and vaccinate citizens, among other things. Does it seem odd that HHS is giving the states a blueprint to consolidate control over their citizens in the event of bioattack?

FDA had already embraced the new regulatory culture. How better to both speed up drug approvals, and save the President the political cost of contravening the Nuremberg Convention than by weakening the current requirements for drug licensing?

After acknowledging that the effectiveness of bioterrorism drugs could not be tested in humans, and therefore animal efficacy tests should be used instead, FDA prepared to throw out the baby with the bathwater. In 1999, hints that human safety testing would be jettisoned as a requirement for licensure began to appear.

The 1999 Annual Report for FDA's Center for Biologics said: "A research program to produce vaccines, therapeutics and drugs to treat [bioterrorism] outbreaks faces the challenge of not being able to proceed with Phase III efficacy clinical trials. Given ethical and safety concerns that would rule out infecting human subjects with a deadly organism in order to test a vaccine or therapeutic for efficacy, trials with humans cannot be undertaken. Therefore, the regulatory process for approval of treatments must be modified to permit the emergency use of antibiotics, therapeutics and vaccines that have been shown to be safe and effective in animal models."

Wait just one minute. Nobody needs to be infected with anything to test drug or vaccine safety. All you do is administer the drug or vaccine, and watch the recipient for possible adverse effects. Could this leap of faith in animal models have been a mistake? After all, it is universally acknowledged that human adverse effects cannot be extrapolated from animal tests. Each species responds uniquely to a drug or vaccine. Vaccines that are safe in some species can be fatal in other species, and this cannot be accurately predicted ahead of time.

Unfortunately, it looks like there is no mistake. The director of FDA's Center for Biologics, Kathryn Zoon, published a paper in "Emerging Infectious Diseases" in which she reiterated the call to fully license drugs for bioterrorism in the absence of any human testing. She said that once licensed, the safety of the drugs can be assessed. It is hard to reconcile this philosophy with Dr. Zoon's role as a federal regulator charged with protecting the public health.

The latest episode in this saga concerns Congress' role in bioterrorism prevention. A bill designed to fund federal bioterrorism efforts, called the "Public Health Security and Bioterrorism Response Act of 2001" was passed in December by both the House (H.R. 3448) and the Senate (Senate Amendment 2692) on the same day it was introduced in both houses. Both the House and Senate versions of the bill contain a provision mandating that FDA finalize and implement a 1999 Notice of Proposed Rulemaking. This action would allow animal efficacy tests to be sufficient to fully license drugs and vaccines intended for bioterrorism. Although safety testing is not explicitly addressed in the bill, given the statements made by FDA above, it appears that safety testing in humans may be waived as well, as a requirement for licensure.

Another way to look at this bill's provision is as a way of getting around the absolute requirement for informed consent. As was pointed out earlier, people are allowed to use experimental drugs and vaccines, as long as FDA has approved the experimental use and the patient or subject has provided informed consent. By licensing what would previously have remained an experimental drug, one opens up the possibility of forced use, with no need for informed consent. The Nuremberg Convention, first nibbled at by mandating use of experimental drugs in the Gulf War theater, looks like it is about to be completely overturned.

This bill is now in conference committee. Congress should be informed that despite having undergone human safety and efficacy tests to be licensed, many drugs and vaccines have still had to be withdrawn from use due to severe side effects, including death. These side effects were usually not discovered until the drugs were given to large numbers of people.

In the case of drugs and vaccines for bioterrorism, it is likely that, following an attack, the entire country will receive a drug or vaccine in a crash program, over days or at most weeks. This leaves no time to assess the adverse event profile of the drug in smaller numbers of people, before it is given to the entire population. If the "Model Law" is used, forced acceptance of drugs or vaccines that have never been tested in a single human could be demanded of the entire U.S. population. One poor choice of a drug or vaccine that is later found to be dangerous could have a dire effect on a very large number of people.

Human safety testing is not something we should allow to go by the board.

RECOMMENDED READING

JAMA 2002;287:612-617 http://jama.ama-assn.org/issues/current/abs/joc11772.html <a href="http://jama.ama-assn.org/issues/current/abs/joc11772.html">Read it here</a>

Horton R. Commentary. Lotronex and the FDA: A fatal erosion of integrity.
The Lancet 2001; 357: 1544-5.

Drug After Drug, Warnings Ignored. With Study Results Ignored, Nation Got Another Blood Pressure Drug. LA Times 2000.

Landow L. FDA Approves Drugs Even When Experts on its Advisory Panels Raise Safety Questions. BMJ 1999; 318: 944.

Friedman MA et al. The Safety of Newly Approved Medicines: Do recent market removals mean there is a problem? JAMA 1999; 281:1728-34.

Wood AJJ. The Safety of New Medicines: The importance of asking the right questions. JAMA 1999: 281: 1753-4.

Lurie P et al. Safety of FDA-Approved Drugs (Letter and reply). JAMA 1999:
282

Angell M and Relman AS. Prescription for Profit. Washington Post, 6/20/2001, A27

Wood AJJ and Woosley R. Making Medicines SaferóThe Need for an Independent Drug Safety Board. NEJM 1998; 339: 1851-4.

Bodenheimer T. Uneasy Alliance: Clinical Investigators and the Pharmaceutical Industry. NEJM 2000: 342: 1539-44.

Brennan TA. Buying Editorials. NEJM 1994: 331: 673-5.

Mucklow JC. Reporting Drug Safety in Clinical Trials: Getting the Emphasis Right. The Lancet 2001; 357: 1384.

Chalmers I. Underreporting Research is Scientific Misconduct. JAMA 1990;
263: 1405-8.

Rochon PA et al. A Study of Manufacter-Supported Trials of Nonsteroidal Anti-Inflammatory Drugs in the Treatment of Arthritis. Achives of Internal Medicine 1994; 154: 157-63. [Conclusion: The manufacturer-associated NSAID is almost always reported as being equal or superior in efficacy and toxicity to the comparison drug. These claims of superiority, especially in regard to side effect profiles, are often not supported by trial data. These data raise concerns about selective publication or biased interpretation of results in manufacturer-associated trials.]

Ionnidis JPA and Lau J. Completeness of Safety Reporting in Randomized Trials. JAMA 2001; 285: 437-43.

Woodward B. Challenges to Human Subject Protections in US Medical Reseaerch.
JAMA 1999: 282: 1947-52. [Conclusion: Nationally and internationally, there are new pressures to subordinate the interests of the subjects to those of science and society. The National Bioethics Advisory Commission, which is about to undertake a comprehensive review of the US system of human subject protections, faces a daunting task.]

Zoon KC. Vaccines, pharmaceutical products, and bioterrorism:
Challenges for the US Food and Drug Administration. Emerging Infectious Diseases 1999;5:534-536.


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12) Gut Thoughts

Abstract

Though few know about it, humans have a second brain that handles most of the body's digestive functions. Study of the enteric nervous system is a rapidly growing specialty, offering insight into malfunctions of the "gut brain" as well as the more complex cranial brain.

Digestion is such a prosaic function that most people prefer not to think about it. Fortunately, they don't have to - at least not with the brain in their heads. Though few know about it, humans (and other animals) have a second brain that handles most digestive functions.

Deep in your gut lies a complex self-contained nervous system containing more nerve cells than the spinal cord, and indeed more neurons than all the rest of the peripheral nervous system. There are over 100 million nerve cells in the human small intestine alone.

Malfunctions of this "gut brain" may be involved in irritable bowel syndrome (IBS), a condition that affects an estimated 20 percent of the U.S.
population and is believed to be responsible for $8 billion in health care costs alone in the United States each year, according to the International Foundation for Functional Gastrointestinal Disorders. Patients with IBS suffer bouts of chronic diarrhea, constipation, or sometimes both alternately. IBS is the most common diagnosis made by gastroenterologists.

The study of the enteric nervous system is a rapidly growing specialty known as neurogastroenterology.

"What the gut has to do is extremely complicated," says Michael Gershon, chair of the department of anatomy and cell biology at the Columbia University College of Physicians and Surgeons and author of The Second Brain (Harper Perennial, 1999). "If the brain had to control that, it would have to run huge cables and have a huge number of cells devoted solely to that purpose. It makes great evolutionary sense to [separate these functions] and essentially use a microcomputer that is independent rather than a central processing unit."

In fact, researchers believe that the gut brain evolved first - because digestion came before locomotion in multicellular creatures. In mammals, the two systems originate near each other in the outer layer of the early embryo.

Like many poorly understood organs, the gut brain was discovered by classical anatomists in the 19th century and then ignored. "No one knew what it did," says David Wingate, emeritus professor of gastrointestinal science at Queen Mary, University of London. "When you'd ask what it was for in medical school, they'd say, 'Let's move on.'"

In 1899, physiologists studying dogs found that unlike any other reflex, the continuous push of material through the digestive system (now called the peristaltic reflex) continued when nerves linking the brain to the intestines were cut.

By the 1970s, a society for the study of gastrointestinal motility had been set up - but how this motility was controlled remained unclear. The vagus nerve, for example, sends some fibers from the brain to the gut; however, it connects directly with only a tiny minority of cells there.

In 1965, Gershon published a paper in Science suggesting that serotonin might act as a neurotransmitter in the gut. At the time, acetylcholine and norepinephrine were accepted as transmitters in the peripheral nervous system, but serotonin was seen as a centrally acting transmitter used by some nerves to modulate the action of others.

The peripheral nervous system wasn't supposed to use such controls - only the brain and spinal cord were believed to process information through "interneurons" such as those containing serotonin.

At a meeting of the Society for Neuroscience in 1981, however, Gershon and others marshaled enough data to finally convince skeptics that serotonin was indeed a key transmitter in the gut.

In fact, it is now known that 95% of the body's serotonin is used by the gut - and the enteric nervous system contains every neurotransmitter and neuromodulator found so far in the brain.

"We now know quite a lot about the library of programs run by the [gut brain]," says Jackie Wood, professor of physiology and cell biology and of internal medicine at Ohio State University. "For example, when the bowel is empty, one particular program runs." Called the migrating motor complex (MMC), this involves a series of movements running from the stomach to the end of the small intestine, which is believed to function in keeping the potentially dangerous bacteria stored in the colon from moving upwards rather than out.

At least 500 different species of deadly bacteria have been found to inhabit a person's colon at any given time; "traveler's diarrhea" often results when this mix is changed through exposure to new pathogens. If this happens, the gut runs a program designed to expel as much of its contents as quickly as possible - unpleasant for the vacationer, but much better than a fatal infection.

"Another program involves a flood of serotonin throughout the entire circuit, which produces the digestive pattern that mixes and stirs the contents," says Wood.

Because the gut brain is smaller and more accessible than the brain itself, understanding it could offer insights about how to parse the more complex organ. "[That idea] was what lead me to begin my research when I was a fledgling neuroscientist," says Gershon. "I looked at the brain and found it daunting, and I still do, so I looked for a simpler nervous system to study." He adds, "'Simple nervous system,' of course, turned out to be an oxymoron."

Unlike the cranial brain, however, the gut brain doesn't seem to be conscious - or at least, in health, it doesn't impinge much on consciousness. "The gut is not an organ from which you like to receive frequent progress reports," says Gershon. For most digestive processes, no news is good news.

The problem in IBS, in fact, may be that the enteric nervous system becomes overly sensitive to normal functioning and reports to the brain when it shouldn't. Or, the brain may overreact to normal bowel signals.

Normally, the brain may avoid conscious awareness of most gut activity. But in IBS, says Wingate, one theory is that "the barrier to information being projected into consciousness is lowered."

As in many heterogeneous conditions defined by symptoms rather than specific pathology, different subgroups of patients may have different causes or varying levels of contributions by different factors.

In some cases, IBS may be an autoimmune problem - something like multiple sclerosis of the gut, where immune cells attack nervous tissue. "If you catch it early enough," says Wood, "You can use steroids to treat it [in such cases]." High doses of steroids shut down immune activity and prevent immune cells from causing harm, but they don't help once damage has been done.

The gut is, in fact, a major immune organ, containing more immune cells than the rest of the body combined. The enteric nervous system interacts intimately with the immune system, and can affect mood and behavior by signaling the central nervous system.

Further, the gut brain may in fact be the only system that can refuse central signals. Says Gershon, "The gut brain can say no to the big brain, absolutely. In fact, there are nerve fibers that project towards the CNS, and if the [bowel] doesn't like the message, it can turn it off or cancel it."

Indeed, the vagus nerve mostly carries information from the enteric nervous system to the brain - for every one message sent by the brain to the gut, about nine are sent in the other direction. And recent research has found that stimulating this nerve can have antidepressant and even learning-enhancing effects - so "gut feelings" could genuinely be more than just a metaphor.

The similarities between the two nervous systems may also mean that they are vulnerable to similar toxins and disease processes. For example, in both Parkinson's disease and Alzheimer's, the degenerative processes seen in brain nerve cells are also seen in the neurons of the enteric system.

This link could also help explain the connection between psychological problems and gut problems - and could put to rest the myth that problems such as IBS are simply "neuroses" because they so often occur in people with other psychological disorders.

It may be that the real reason that bowel disorders often accompany psychological problems is that both brain and gut neurons are suffering simultaneously - in addition to the fact that having to spend a significant portion of one's life attending to bathroom functions is in itself depressing.

Simultaneous effects of drugs on both systems also account for the gastrointestinal "side effects" of Prozac and other drugs that act on serotonin metabolism - which actually may have more effect on the bowel than on the brain, because serotonin predominates in the bowel and the drug moves through the digestive system before reaching the brain.

Fortunately, in most people, the bowel quickly develops tolerance to these drugs, and gastrointestinal side effects usually subside within a few days or weeks of the start of treatment. In fact, low doses of SSRI (selective serotonin reuptake inhibitor) drugs may actually help patients with IBS.
And since different serotonin receptors predominate in the brain and in the gut, new drugs may be developed to affect certain subtypes but not others.

"What's exciting," says Wingate, "is getting away from essentially anecdotal ways of categorizing patients by symptoms and being able to study [their problems] in a very systematic biological way."

Maia Szalavitz is a health/science journalist who has written for the New York Times, the Washington Post, Newsday, New York Magazine, Salon, and other major publications.

http://news.bmn.com/hmsbeagle/119/notes/feature1 <a href="http://news.bmn.com/hmsbeagle/119/notes/feature1">Read it here</a>


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12) Relationships Between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry

Niteesh K. Choudhry, MD, FRCPC; Henry Thomas Stelfox, MD, FRCPC; Allan S.
Detsky, MD, PhD, FRCPC

Context Increasing contact has been reported between physicians and the pharmaceutical industry, although no data exist in the literature regarding potential financial conflicts of interest for authors of clinical practice guidelines (CPGs). These interactions may be particularly relevant since CPGs are designed to influence the practice of a large number of physicians.

Objective To quantify the extent and nature of interactions between authors of CPGs and the pharmaceutical industry.

Design, Setting, and Participants Cross-sectional survey of 192 authors of
44 CPGs endorsed by North American and European societies on common adult diseases published between 1991 and July 1999. One hundred authors (52%) provided usable responses representing 37 of 44 different CPGs that we identified.

Main Outcome Measures Nature and extent of interactions of authors with drug manufacturers; disclosure of relationships in published guidelines; prior discussion among authors regarding relationships; beliefs regarding whether authors' own relationships or those of their colleagues influenced treatment recommendations in guidelines.

Results Eighty-seven percent of authors had some form of interaction with the pharmaceutical industry. Fifty-eight percent had received financial support to perform research and 38% had served as employees or consultants for a pharmaceutical company. On average, CPG authors interacted with 10.5 different companies. Overall, an average of 81% (95% confidence interval,
70%-92%) of authors per CPG had interactions. Similarly, all of the CPGs for
7 of the 10 diseases included in our study had at least 1 author who had some interaction. Fifty-nine percent had relationships with companies whose drugs were considered in the guideline they authored, and of these authors,
96% had relationships that predated the guideline creation process.
Fifty-five percent of respondents indicated that the guideline process with which they were involved had no formal process for declaring these relationships. In published versions of the CPGs, specific declarations regarding the personal financial interactions of individual authors with the pharmaceutical industry were made in only 2 cases. Seven percent thought that their own relationships with the pharmaceutical industry influenced the recommendations and 19% thought that their coauthors' recommendations were influenced by their relationships.

Conclusions Although the response rate for this survey was low, there appears to be considerable interaction between CPG authors and the pharmaceutical industry. Our study highlights the need for appropriate disclosure of financial conflicts of interest for authors of CPGs and a formal process for discussing these conflicts prior to CPG development.

JAMA. 2002;287:612-617

Disclaimer: This study received no financial support from the pharmaceutical industry.


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14) How Stuff Works

This informative site has a section covering various body and nutrition questions. It is created in a fun and easy to follow manner so that you and your kids will understand the topics better. You will learn: How fat cells work; How dieting works; How calories work ;How caffeine works And much more! Visit them at: http://www.howstuffworks.com/category.htm?cat=Nutr <a href="http://www.howstuffworks.com/category.htm?cat=Nutr">Read it here</a>


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15) Tegaserod Benefits Some Women with Irritable Bowel By Elda Hauschildt

Journal of Clinical Gastroenterology

Serotonin plays a role in gastrointestinal tract physiology.

A serotonin-related medication used to treat gastrointestinal problems is tegaserod, a selective serotonin receptor subtype 4 (5-HT4) partial agonist. It is designed to interact with the network of cells and nerves throughout the gastrointestinal tract that use serotonin.

United States researchers point out that tegaserod has been shown to be of benefit to women with irritable bowel syndrome (IBS) who have particular symptoms. These include abdominal pain, bloating and constipation.

Investigators from Johns Hopkins University School of Medicine in Baltimore, Maryland comment: "Tegaserod has been shown to modulate both gastrointestinal motility and visceral sensitivity.

"Specifically, it increases the peristaltic reflex and decreases visceral sensitivity.

"Clinical studies have shown that tegaserod improves symptoms of abdominal pain, bloating and constipation in women with IBS."

Journal of Clinical Gastroenterology, 2002; 34: 27-33. "Tegaserod: A New
5-HT4 Agonist"


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16) CAA Releases CFIDS Public Service Announcement

The CFIDS Association of America has released the first national public service announcement (PSA) on CFIDS for television, featuring U.S. Surgeon General Dr. David Satcher. The PSA emphasizes that CFS is a serious, complex medical disorder that can affect people of all races and walks of life. Dr.
Satcher validates the illness, saying that "We may not know the cause of [CFIDS], but the pain and suffering are real."

Background:
Since 1995, CFIDS patients have been asking the U.S. Department of Health and Human Services (HHS) during meetings of the CFS Coordinating Committee (CFSCC) to fund and distribute a PSA on the illness. A PSA is a short message designed for radio, print or television distribution that informs the general public about a particular issue and promotes positive actions, such as those encouraging better safety or health.
In late October 2001, HHS agreed to lend the use of their studio for the PSA, and video footage of Dr. Satcher and several local Washington, D.C.
CFIDS patients was shot there. Unfortunately, shortly afterwards Dr. Satcher announced that he would be leaving office in February 2002, which imposed a severe time limitation on production of the PSA. HHS did not provide funds for production and distribution, but the CFIDS Association rose to the task.

Thanks to help from Jon Sterling, Chairman of the Association's Board of Directors and the guiding force behind the PSA, the Association's public relations firm and a producer for a national news program who was willing to edit the video footage pro bono, the PSA was completed for release on time.

To view the 30-second PSA, visit the Association's web site at http://www.cfids.org/about/psa-intro.asp <a href="http://www.cfids.org/about/psa-intro.asp">Read it here</a>

Distribution A media alert announcing the availability of the PSA on CFIDS has been sent to more than 500 television stations across the nation.

Broadcast-ready tapes are also being mailed to a select group of reporters.

Patients are also invited to give the CFIDS Association names of television reporters or producers in their local area who have shown a previous interest in CFIDS, so that we can ensure they are notified about the PSA.

Send your suggestions to mailto:rmbr-@cfids.org Transcript Availability The Association's CFIDS PSA can be adapted into radio or print PSAs that patients or support groups can distribute in their local area.

If you would like a copy of the PSA script to use in your own awareness efforts, please send an e-mail to lmos-@cfids.org or call the Resource Line at 704-365-2343.

Renee Brehio Director of Communications The CFIDS Association of America Advocacy General E-mail: mailto:in-@cfids.org

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