The popular nonsedating antihistamine, available in the same strengths as the prescription version, will cost less over the counter for people without insurance, but more for those with prescription drug coverage.

Ten-milligram tablets are selling for 90 cents to $1.35 each, based on an initial survey of retail outlets, Schering-Plough said. That equates to $27 to $40.50 for a 30-day supply — more expensive than the $5 to $10 copayment for many patients with a prescription plan.

Nonprescription Claritin, the first nonsedating antihistamine on the market without a doctor's prescription in this country, is being sold in three once-a-day formulations, a twice-a-day formulation and a syrup for children as young as two years old.

Schering-Plough initially fought the health insurance industry's push to switch the drug to non-prescription status; Claritin accounts for one-third of the Kenilworth company's roughly $9 billion in annual revenues. Faced with expiration of Claritin's main patent this month and the prospect of both generic and nonprescription competition, Schering-Plough backed down.

The switch could result in prescription plans refusing to cover other prescription-only antihistamines, such as Allegra, Zyrtec and Clarinex, Schering-Plough's successor drug to Claritin, or charging patients much higher copayments for those medicines.

New AIDS Drug

A new type of AIDS drug may be coming to the market a little

sooner than expected. The Food and Drug Administration has

granted a priority six-month review for the experimental drug

Fuzeon, which would be used to treat people with drug-resistant

strains of HIV, The Associated Press reports. The drug belongs

to a new class of drugs called fusion inhibitors, which block HIV

from entering cells. In clinical trials, people with drug-

resistant HIV who added Fuzeon to their drug regimen were twice

as likely to see their virus levels decrease to undetectable

levels than people not taking the new drug, the AP says.

However, the drug is difficult to produce and so would likely be

very expensive, and may cost as much as ,000 to ,000 per

year per patient, the AP says.

How to Break a Blockbuster Drug in Half

The diamond-shaped erection pill costs the same (almost $10 each) whether you get the 25-milligram, 50-milligram or 100-milligram version. This flat-pricing strategy has led many in the over-50 crowd to buy the larger pill and try breaking it up into smaller pieces.

"The patient should be taking a drug based on the dosage recommended by the physician," says Dr. Ira Sharlip, president of the Sexual Medicine Society of North America. "But I can tell you it's common practice for physicians to recommend a dose of 50 milligrams and write a prescription for a 100-milligram tablet."

The ploy could double your fun, but try turned out to be the operative word.

Carmen Reitano, 71, an inventor and Viagra user, was changing in the locker room of his gym not too long ago when the conversation turned to the hazards and difficulties of pill-splitting.

"It explodes," complained one man.

"You can't split it," said another.

"You cut it with a knife and it splits apart with such fury it bounces off the wall, then you have to go find the pieces," said a third.

Reitano had never tried splitting his Viagra pills even though his insurance company only prescribed four a month. After hearing the boys talk, though, he decided to give it a whirl. He went home, took out the kitchen knife and tried to cut open one of his Viagra pills. Nothing happened. He went at it with an X-acto knife blade. Nothing. A hammer. Still, nothing.

Sharlip says his patients have been able to cut their Viagra with store-bought pill-splitters, "and they've worked." However, many others insist the odd-shaped drug doesn't come apart easily.

"The conclusion you come to is that it was purposefully designed to resist splitting," Reitano says. "It's not flat. It's awkward to hold. There's no scoring on the covering." He also discovered that the internal medication is not always bound into a solid block, which is why would-be splitters report that it explodes or breaks apart.

Reitano, who holds several patents, was not to be dissuaded. "It struck me that this pill is made just like wallboard," he says. "It has plaster encapsulated in construction paper. And the way you break that is you score one side and you hit it on the other and it breaks on the fault line."

With this principle in mind, Reitano used standard PVC pipe fitting fixtures to assemble a prototype and took it to the firm that had manufactured one of his other products, an antenna protector for the Motorola StarTAC cell phone. The company built a prototype, tested it, and, lo and behold, it worked.

On Nov. 5, Reitano was awarded patent No. 6,474,525 from the U.S. Patent and Trademark Office for his "pill splitter for complex pill forms." The actual product, the V2 Pill Splitter, is available in two sizes: the 50-milligram pill and the 100-milligram pill.

Now Reitano, who has been married to the same woman for 47 years, is a splitter. And the ranks are growing as men from all over the world purchase the item (for $24.95) directly from Reitano's Web site, www.v2pillsplitter.com. Pfizer, which manufactures Viagra, did not return a call for comment. However, the company recommends against pill-splitting on its Web site.

A Boston urologist told Reitano that more than half of his patients are now splitting pills (after asking the doctor for permission, of course). And a man from New York City called Reitano to tell him that the pill splitter was saving him $1,000 a year. "God bless you," Reitano responded.

What To Do

You can get a primer on erectile dysfunction from the National Institutes of Health. And the U.S. Food and Drug Administration (news - web sites) has more on Viagra

New Drug Tops Gold Standard in Breast Cancer Trial

Thu Mar 21, 1:13 PM ET

By Patricia Reaney

BARCELONA, Spain (Reuters) - A new breast cancer (news - web sites) drug is better than the best currently available treatment in preventing postmenopausal women with early disease from developing a new tumor in the other breast, researchers said Thursday.

The drug, called anastrozole, is produced by AstraZeneca PLC under the brand name Arimidex.

In research presented at the 3rd European Breast Cancer Conference, scientists said the drug outperformed tamoxifen, currently the gold standard for treatment, in a trial of women with early breast cancer.

Women who were given anastrozole for two and a half years had a 58% lower risk of developing a new tumor in the other breast than those taking tamoxifen, which is also made by AstraZeneca.

"It is an important finding. The reduction in the development of contralateral (other) breast cancer was very much greater than we had anticipated," Dr. Jeffrey Tobias of University College Hospital London, one of the researchers on the study, told Reuters.

Tamoxifen cuts the risk of a new cancer in the other breast by 50% and anastrozole slashes it in half again.

The study, one of the largest breast cancer trials ever conducted, involved more than 9,000 women who were given either anastrozole, tamoxifen or a combination of both. The combination therapy was no better than tamoxifen alone.

Anastrozole works by inhibiting production of the female hormone estrogen in postmenopausal women. Estrogen is linked to the development of cancer, and most cases of breast cancer are in postmenopausal women.

But the drug does not work in younger women and it may increase the risk of fractures or osteoporosis.

Tobias said women given anastrozole had fewer side effects such as blood clots, hot flushes and cancer of the uterus than the tamoxifen group.

new teste for celiac diseaseLancet 2002; 359: 945-46.

The clinicians said the immunochromatographic assay detects antibodies to transglutaminase quickly and easily. It is highly accurate in detection of untreated patients with coeliac disease, and detects both IgA and IgG antibodies to transglutaminase, and which can prevent the misdiagnosis of patients with a deficit of IgA, a frequent trait of coeliac disease.

Journal of the National Cancer Institute, Vol. 94, No. 5, 391-398, March 6, 2002

Prospective Study of Tomato Products, Lycopene, and Prostate Cancer Risk

Edward Giovannucci, Eric B. Rimm, Yan Liu, Meir J. Stampfer, Walter C. Willett

Affiliations of authors: Channing Laboratory, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA; Departments of Nutrition and Epidemiology, Harvard School of Public Health, Boston.

Correspondence to: Edward Giovannucci, M.D., Sc.D., Department of Nutrition, Harvard School of Public Health, 665 Huntington Ave., Boston, MA (e-mail: edward.giovannucci@channing.harvard.edu).

Background: Some data, including our findings from the Health Professionals Follow-Up Study (HPFS) from 1986 through January 31, 1992, suggest that frequent intake of tomato products or lycopene, a carotenoid from tomatoes, is associated with reduced risk of prostate cancer. Overall, however, the data are inconclusive. We evaluated additional data from the HPFS to determine if the association would persist. Methods: We ascertained prostate cancer cases from 1986 through January 31, 1998, among 47 365 HPFS participants who completed dietary questionnaires in 1986, 1990, and 1994. We used pooled logistic regression to compute multivariate relative risks (RR) and 95% confidence intervals (CIs). All statistical tests were two-sided. Results: From 1986 through January 31, 1998, 2481 men in the study developed prostate cancer. Results for the period from 1992 through 1998 confirmed our previous findings—that frequent tomato or lycopene intake was associated with a reduced risk of prostate cancer. Similarly, for the entire period of 1986 through 1998, using the cumulative average of the three dietary questionnaires, lycopene intake was associated with reduced risk of prostate cancer (RR for high versus low quintiles = 0.84; 95% CI = 0.73 to 0.96; Ptrend = .003); intake of tomato sauce, the primary source of bioavailable lycopene, was associated with an even greater reduction in prostate cancer risk (RR for 2+ servings/week versus <1 serving/month = 0.77; 95% CI = 0.66 to 0.90; Ptrend<.001), especially for extraprostatic cancers (RR = 0.65; 95% CI = 0.42 to 0.99). These associations persisted in analyses controlling for fruit and vegetable consumption and for olive oil use (a marker for Mediterranean diet) and were observed separately in men of Southern European or other Caucasian ancestry. Conclusion: Frequent consumption of tomato products is associated with a lower risk of prostate cancer. The magnitude of the association was moderate enough that it could be missed in a small study or one with substantial errors in measurement or based on a single dietary assessment.

From

Medscape News

MedscapeWire

New Acne Drug Has Fewer Adverse Effects

By Jennifer Warner

CHICAGO (MedscapeWire) Dec 18 - A powerful new drug for acne may work without adverse effects, according to Canadian researchers. They presented their data at the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy on Sunday.

More than 85% of adolescents suffer from some form of acne, and nearly one-fifth of all visits to dermatologists are prompted by the need for effective acne treatment. Although antibiotics have been used for more than 30 years to treat acne, the bacterium responsible the most common form of acne is growing increasingly resistant to standard treatments.

Newer prescription treatments, such retinoids that are derived from vitamin A, can provide relief for some sufferers, but the drugs also carry the risk of potentially severe effects such as birth defects and psychological disorders.

The new drug, currently known as MBI 594AN, appears to attack acne-causing bacteria so quickly that they don't have a chance to become resistant.

"This product seems to kill very rapidly - it attacks the cell walls and reduces lesions quite quickly," says Jenny Robinson, MD, manager of medical affairs at Micrologix Biotech, the Vancouver-based company that developed the drug.

Robinson says the preliminary tests also show that MBI 594AN, which is a topical alcohol-based solution, also has the potential to reduce the inflammation associated with acne lesions.

Because the naturally derived active ingredient isn't absorbed into the bloodstream, researchers say it reduces the likelihood of adverse effects seen in other acne medications.

The drug is currently in phase II clinical testing and has not yet been approved for use by the US Food and Drug Administration. Researchers say they hope to have the drug on the market within the next few years.

Jennifer Warner is a medical writer with Medscape Health, Medscape's sister site for patients.

MedscapeWire is edited by Deborah Flapan, an associate editor at Medscape. Send press releases and comments to medscapewire2@medscapeinc.com.

New York Scores Well on U.S. Air-Pollution Report Card

WASHINGTON (Reuters) - New York won the highest ranking and Oklahoma City the lowest among the 50 largest US cities for spending on mass transit and reducing smog from cars and trucks, according to a Sierra Club (news - web sites) air pollution report card issued on Tuesday.

Although cars today produce much less air pollution than a generation ago, people are driving more. The average American driver spends about 443 hours per year--the equivalent of 55 eight-hour workdays--behind the wheel, the green group said.

New York won the highest grade in the Sierra Club report, an A, for its spending on public transit.

The city is the only one in the nation that spent more money on transportation alternatives than on new roads. New York spent $460.69 per person on mass transit and $360.97 per person on highways.

At the same time, New York emitted the least amount of smog per person from cars and trucks, about 54 pounds annually, according to the green group.

On the other end of the spectrum, Oklahoma City flunked the Sierra Club analysis. The city had a high amount of smog from cars and trucks, 137 pounds per person per year, and spent just $15.31 per person on public transit and $262.96 per person for highway construction.

During the study, patients were continuously infused with Genasense for five days and then treated with a standard regimen of the anticancer-drugs fludarabine, cytarabine, and filgrastim.

Of the 20 patients, nine showed signs that all leukemia cells in the blood and bone marrow had disappeared, indicating that these patients had gone into complete remission.The researchers also point out that the side effects associated with chemotherapy, including fever, nausea, and vomiting, did not occur at higher-than-expected levels, suggesting that that the Genasense did not increase the toxicity of the chemotherapy.

"This is a very encouraging first step, which suggests that Genasense may have a role in making leukemia patients sensitive to chemotherapy again," Marcucci noted in a written statement.

"Genasense would probably be effective in treating several different types of cancer, but only those that express Bcl-2," Marcucci told Reuters Health.

According to Marcucci, some other cancers that may be helped by this drug include Hodgkin's lymphoma and melanoma. "In general, I would say that this drug would be useful for every type of cancer that would overexpress Bcl-2," he said.

From

Medscape News

MedscapeWire

New Sepsis Treatment Cuts Death Risk Almost 20%

May 23, 2001

By Deborah Flapan

New York - A new treatment for severe sepsis reduces the relative risk of death by almost 20%, according to a study presented Tuesday at the American Thoracic Society's 97th International Conference in San Francisco, California.

The treatment, recombinant human activated protein C (rhAPC), has the potential to have a major impact on mortality rates for severe sepsis, said lead study author Gordon Bernard, MD, Professor of Medicine at Vanderbilt University in Nashville, Tennessee. "There are up to 750,000 sepsis cases in the United States each year, and the death rate is in the 30%-35% range," said Dr. Bernard, who is also Associate Director of the Division of Allergy, Pulmonary and Critical Care Medicine.

Sepsis is a serious infection caused by bacteria or other microorganisms that have entered a wound or body tissue. Tissue damage and a dramatic drop in blood pressure result from the presence of these organisms, their toxins or other products in the blood. People with diseases such as diabetes and cancer that compromise the immune system are at higher risk of developing sepsis. Sepsis sometimes develops as a complication of pneumonia or meningitis, or as a result of perforated appendix or ulcer, or of any trauma that damages a body cavity. When sepsis develops, the body tries to "wall off" the infection to keep it from spreading. One way it does this is by coagulating blood in small vessels, in an attempt to prevent the infection from draining to the rest of the body. "But severe sepsis involves the entire body, and the immune system can't wall it off," Dr. Bernard said. "Instead, this coagulopathy occurs throughout the body and ends up damaging tissues and organs, sometimes with deadly results."

In trying to counteract the clotting, the body uses a substance called Protein C, but levels of this protein are depleted very quickly. The new treatment is a human recombinant version of the protein, which limits and reverses the coagulopathy and thus counteracts damage to tissue and organs, and improves survival, Dr. Bernard said.

The phase III multicenter, international study included 850 severe sepsis patients who received rhAPC and 840 patients who received a placebo. Treatment was administered intravenously for 96 hours. Twenty-eight days later, 24.6% of patients receiving rhAPC had died, compared with 31.4% in the control group.

"We conducted a battery of tests to measure the blood's coagulation status and found substantial abnormalities before the treatment, and we saw a restoration of more normal values after treatment," Dr. Bernard said.

Eli Lilly and Company, which manufactures rhAPC, submitted a New Drug Application under the brand name Zovant to the US Food and Drug Administration in January 2001.

MedscapeWire is edited by Deborah Flapan, an associate editor at Medscape. Send press releases and comments to medscapewire2@medscapeinc.com

NOTE: To view the article with Web enhancements, go to:

http://www.medscape.com/Medscape/ID/journal/2001/v03.n04/mid0807.stee/mid0807.stee-01.html

Expert Column

Pediatric ID Update: An Itch in Time... Practical Treatment of Tinea Capitis

Robert W. Steele, MD

Introduction

Tinea capitis, or ringworm of the scalp, is a common condition diagnosed frequently in the primary care physician's office. This infection, while not a particularly deadly illness, can often inspire fear and dread in many parents whose children have acquired it. There is myth and mystery surrounding this condition, and parents may consider its acquisition to reflect on their hygiene techniques. Aside from learning the causes and treatment of tinea capitis, it is important for the primary care physician to recognize the true epidemiology in order to give parents accurate anticipatory guidance to avoid the "dreaded" ringworm.

The etymology of the word ringworm reveals that the term came into use in the 15th century and was used to describe any skin rash that was patterned in a ring formation.[1] However, it wasn't until the mid-1800s that formal microscopic examination revealed that the true etiology of hair loss was from dermatophyte invasion. Several species of fungus were identified at the end of the 19th century as causing tinea capitis, and straightforward culture methods were developed to aid in their isolation.[2]

There are now more than 40 species of fungi recognized to commonly invade the skin and/or hair. Six of these represent the most common causes of tinea capitis (Table 1). These fungi may be found in soil, on humans, or on pets commonly found in the home, and the relative frequency of a species is often determined simply by geography. Trichophyton tonsurans has now supplanted Microsporum canis as the most common dermatophyte to cause tinea capitis in the United States.[3] This is contrasted with Europe, where M canis continues to play a major role in infection.

While tinea capitis can affect all children, poorer children and those residing in crowded living conditions may be more at risk for infection. Hair care practices, including hairstyle, frequency of washing, and the use or nonuse of hair conditioner, oils, or grease, do not appear to play a significant role in acquiring tinea capitis.[4] When cases arise in a household, there is a high prevalence of an asymptomatic carrier within the home.[5] It is common for tinea capitis to be spread through combs, hairbrushes, and fallen infected hairs. And since untreated asymptomatic carriers may continue their carrier status even 2 months later, it has been recommended that all members of the household be treated simply to eliminate any carriers within the family.[6]

Tinea capitis may appear clinically in several typical scenarios. The hair may simply show some thinning with a scaly appearance to the scalp. The hair may be almost absent due to hair breakage, giving the scalp a "dotted" appearance where the hair stump remains in the scalp. This often gives a distinct border of hair loss. There may not only be hair loss but significant inflammation producing pustules, keratin accumulation, and kerion formation. Each of these clinical entities may be associated with occipital or cervical lymphadenopathy.

Treatment Options

Tinea capitis is caused by invasion of the hair by dermatophytes. Because there is direct invasion, topical therapy is usually inadequate, simply because it is not possible to effectively get the medication to the site of infection. Therefore, oral therapy is the mainstay of successful eradication. Since its initial use in the 1950s, griseofulvin has remained the treatment of choice for tinea capitis.[7] However, there are now several therapeutic options available. Understanding their pros and cons allow for the appropriate selection to be made (Table 2).

Griseofulvin is a medication derived from Penicillium, which produces its antifungal effect by inhibiting the assembly of microtubules. The drug establishes a high level within the stratum corneum. Then, as the keratin is exfoliated, it is replaced by uninfected tissue.[8] It has a notoriously erratic absorption that is dependent on concurrent dietary fat intake. It is a safe medication with infrequent side effects, which usually subside as the therapeutic course continues.

Itraconazole is a relatively new antifungal medication. It, too, has improved absorption when taken with increased dietary fat. Its concentration in the skin is much higher than that of the plasma because of its high lipophilic properties. In fact, significantly high concentrations remain in the skin even 4 weeks after the medication has been discontinued. This has led to successful use of this medication in children using pulsed dosing of 1 week duration in 2-week intervals.[9] Fluconazole, like itraconazole, is a triazole compound but is quite water soluble. This gives it the advantage of reliable and excellent gastrointestinal absorption regardless of dietary fat intake. However, its dosage must be adjusted in those with renal insufficiency.

Terbinafine is an allylamine antifungal drug that can attain concentrations in the corneum stratum 75 times that of the plasma. Studies in children have shown equivalent effectiveness in eradicating infection when compared with griseofulvin.[11-12]

Clinical experience with each of these newer medications is small. However, with the possibility of shorter duration of treatment, their increased unit cost may be less significant than the decreased cost of total therapy.

The Other Treatment: Information

Finally, it is important for healthcare professionals to give parents reliable information concerning the transmission of tinea capitis, particularly when the infection has been identified in a child in the classroom. The Committee on Infectious Diseases of the American Academy of Pediatrics has stated that children receiving treatment for tinea capitis may attend school. Haircuts, shaving of the head, or wearing a cap during treatment are not necessary.[13] This recommendation is made for a couple of reasons. Asymptomatic carriers within the home most likely play the greatest role in transmission. Thus, as long as fomites such as combs and brushes are not shared, school contact is much less likely to spread infection than infection in the home. Second, it is impractical to keep children out of school for the 4-8 weeks it takes to completely eradicate the infection.[14] It is hoped that more-rapid diagnostic assays will be developed in the future that will aid in identifying those carriers so that more effective treatment strategies can be employed when outbreaks occur.

Table 1. The Most Common Species Responsible for Tinea Capitis

Microsporum canis

Microsporum gypseum

Trichophyton tonsurans

Trichophyton mentagrophytes

Trichophyton violaceum

Trichophyton verrucosum

Table 2. Antifungal Medications for Tinea Capitis

Drug	Recommended Dosages	Recommended Duration of Treatment	Monitor Liver Enzymes?	Liquid Suspension?
Griseofulvin	20 mg/kg/day	6-8 weeks	No	Yes
Itraconazole	5 mg/kg/day	4-6 weeks	Yes	No
Ketoconazole	Not for pediatric use yet	N/A	N/A	No
Fluconazole	6 mg/kg/day	3 weeks	No	Yes
Terbinafine	10-20 kg = 62.5 mg/day 20-40 kg = 125 mg/day > 40 kg = 250 mg/day	2-4 weeks	Yes, if treatment > 4 weeks	No

From

Medscape News

MedscapeWire

Walnuts May Decrease Risk of CVD

July 3, 2001

By Hong Mautz

New York - A new study shows that walnuts can lower low-density lipoprotein (LDL) cholesterol levels and reduce cardiovascular disease (CVD) risk.

Earlier research has suggested that nuts in general provide health benefits, specifically coronary benefits. Some studies have shown that eating 5 servings of nuts per week reduced the risk of heart attacks by 40%-50%. Although there are several theories on the potential mechanisms of the protective effect of nuts, the exact mechanism is unknown.

In this study, published in the July issue of the American Journal of Clinical Nutrition, researchers looked at walnuts exclusively and found that adding walnuts to both regular and low-fat diets significantly reduced total cholesterol as well as the low-density lipoprotein (LDL) cholesterol levels. This finding, researchers say, suggests that the way walnuts lower cholesterol is by changing lipid distribution in favorable ways.

"What's different about walnuts is that they are rich in polyunsaturated fat, while other nuts are rich in monounsaturated fat," says study author Sidika Kasim-Karakas, MD, of the department of endocrinology and nutrition at the University of California at Davis. "We have identified a potential additional mechanism by which walnuts prevent heart disease."

Five men and 13 postmenopausal women (average age, 60 years) who have high cholesterol and high triglyceride levels) participated in the study. They were given 4 diets in sequence over a period of 5.5 months:

Regular (pre-study) diet.

Regular diet + walnuts.

Low-fat diet.

Low-fat diet + walnuts.

Participants were on each diet for 6 weeks. At the end of each diet, researchers measured cholesterol and triglyceride levels. "Wherever we added walnuts, regardless of [whether it was] the second or the fourth phase, we had favorable changes in the small [density] LDL," says Dr. Kasim-Karakas.

"We showed a decrease in small-density LDL from 46% in the regular diet to 33% in the regular plus walnuts diet," says Dr. Kasim-Karakas. More studies on walnuts or nuts in general are needed to understand better the mechanisms of their protective effect, he said.

John Sabaté, MD, DrPH, professor of nutrition at the School of Public Health at Loma Linda University, California, who has done extensive research on walnuts, says that his studies have shown that eating walnuts lowered cholesterol among both healthy men and women as well as people with high cholesterol.

"This study confirms our previous results that walnuts reduce lipoprotein cholesterol levels," says Sabaté. "Supplementation of walnuts lower[s] not only the total amount of cholesterol, but the LDL cholesterol, preferentially lower[ing] the small particle LDL."

But Dr. Sabaté points out that it is difficult to distinguish the precise effects of different diets because they were administered consecutively. "The results need to be repeated, especially on the small LDL," says Sabaté.

One interesting point in the study is that walnuts did not increase weight in people who consumed walnuts in addition to their regular diets, says Lola O'Rourke, MS, RD, a spokesperson for the American Diatetic Association.

"Although the mechanism is not entirely clear, one theory is that nuts are very satiating, they give a sense of satisfaction so people stop eating sooner," Ms. O'Rourke explains.

O'Rourke points out that over the last few years, fat intake has gone down, yet the number of Americans who are overweight has gone up. One reason may be that there are many low-fat and non-fat products popping up on the market, and people are probably eating more of them.

"Many people in our society are 'fat phobic,' and nuts are often perceived as something that should be avoided for that reason," says O'Rourke. "It's important to keep in mind that some fat is still a good thing. The basis of a balanced diet is variety and moderation. Nuts fit into that extremely well."

Am J Clin Nutr. 2001;73(7):000-000

Hong Mautz is senior news writer with CBS Healthwatch, Medscape's sister site for patients.

MedscapeWire is edited by Deborah Flapan, an associate editor at Medscape. Send press releases and comments to medscapewire2@medscapeinc.com.

Two Controlled Trials of Antibiotic Treatment in Patients with Persistent Symptoms and a History of Lyme Disease

Mark S. Klempner, M.D., Linden T. Hu, M.D., Janine Evans, M.D., Christopher H. Schmid, Ph.D., Gary M. Johnson, Richard P. Trevino, B.S., DeLona Norton, M.P.H., Lois Levy, M.S.W., Diane Wall, R.N., John McCall, Mark Kosinski, M.A., and Arthur Weinstein, M.D.

ABSTRACT

Background It is controversial whether prolonged antibiotic treatment is effective for patients in whom symptoms persist after the recommended antibiotic treatment for acute Lyme disease.

Methods We conducted two randomized trials: one in 78 patients who were seropositive for IgG antibodies to Borrelia burgdorferi at the time of enrollment and the other in 51 patients who were seronegative. The patients received either intravenous ceftriaxone, 2 g daily for 30 days, followed by oral doxycycline, 200 mg daily for 60 days, or matching intravenous and oral placebos. Each patient had well-documented, previously treated Lyme disease but had persistent musculoskeletal pain, neurocognitive symptoms, or dysesthesia, often associated with fatigue. The primary outcome measures were improvement on the physical- and mental-health–component summary scales of the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36) — a scale measuring the health-related quality of life — on day 180 of the study.

Results After a planned interim analysis, the data and safety monitoring board recommended that the studies be discontinued because data from the first 107 patients indicated that it was highly unlikely that a significant difference in treatment efficacy between the groups would be observed with the planned full enrollment of 260 patients. Base-line assessments documented severe impairment in the patients' health-related quality of life. In intention-to-treat analyses, there were no significant differences in the outcomes with prolonged antibiotic treatment as compared with placebo. Among the seropositive patients who were treated with antibiotics, there was improvement in the score on the physical-component summary scale of the SF-36, the mental-component summary scale, or both in 37 percent, no change in 29 percent, and worsening in 34 percent; among seropositive patients receiving placebo, there was improvement in 40 percent, no change in 26 percent, and worsening in 34 percent (P=0.96 for the comparison between treatment groups). The results were similar for the seronegative patients.

Conclusions There is considerable impairment of health-related quality of life among patients with persistent symptoms despite previous antibiotic treatment for acute Lyme disease. However, in these two trials, treatment with intravenous and oral antibiotics for 90 days did not improve symptoms more than placebo.

Germ Warfare For Tumors

A virus harmless to healthy cells may be a deadly weapon against

cancerous ones. In a study published in the Journal of the

National Cancer Institute, researchers used reovirus, a bug

commonly found in human lungs and digestive systems, to shrink

brain tumors in mice. The researchers say a clinical trial using

reovirus to fight cancer in humans could be underway in about six

months, The Associated Press reports. In the study, researchers

implanted an aggressive form of brain cancer called glioblastoma

into 24 mice. Half the mice were then given live reovirus

injections and the other half were given injections of dead

reovirus. The mice who got dead reovirus injections quickly dies

from their cancer, but eight of the 12 mice who got live reovirus

injections were still alive 90 days later. Those mice even

gained weight and appeared healthy, the AP reports. The

researchers say that normal healthy cells are able to block

infection from reovirus, which is why it normally does not cause

illness. But cancer cells are susceptible to infection, and so

can be killed by reovirus, they say. The lead researcher owns

stock in the company that may conduct the human trials of the

reovirus therapy, the AP says.

For more on cancer, go to: http://www.intelihealth.com/IH/ihtIH/EMIHC000/8096/8096.html

Blood Pressure Drugs Fend Off Stroke

A combination of blood pressure medication and diuretics could be

a lifesaver for stroke patients. A study presented at the

European Society of Hypertension meeting in Milan finds that this

drug combination may halve a patient's risk of having a second

stroke, The Associated Press reports. In the study, 6,100 stroke

patients worldwide were given a combination of the ACE inhibitor

Aceon and the diuretic Lozol or else dummy pills for a period of

four years. The results: 150 of the patients taking the drug

combination had a stroke, compared to 255 of the patients taking

the placebo. The drug combination lowered risk even in patients

who'd had normal blood pressure, the AP says. The patients

taking Aceon and Lozol also had lower risk of complications such

as heart attack or dementia, the AP says. The question that

remains is whether it is the lower blood pressure or some other

effect of the drugs that provides the benefit. The study was

partly funded by the French pharmaceutical company Servier, which

manufactures Aceon.

For more on stroke, go to: http://www.intelihealth.com/IH/ihtIH/EMIHC000/8772/8772.html

This Doctor's Guide DGReview has been recommended by Dr. Bruce Roseman

Title: Early Antibiotics Prevent Lyme Disease After Deer Tick Bite

A DGReview of : Prophylaxis with Single-Dose Doxycycline for the Prevention of Lyme Disease after an Ixodes scapularis Tick Bite

New England Journal of Medicine (NEJM)

Casodex (Bicalutamide) Significantly Reduces Risk of Prostate Cancer Progression

TORONTO, ON -- June 20, 2001 -- A once daily dose that slows disease progression offers new hope for hundreds of thousands of men around the world diagnosed with prostate cancer each year.

The first results of the largest ever trial in prostate cancer, the Early Prostate Cancer (EPC) Programme, showed that, in comparison with standard care alone (surgery, radiotherapy or watchful waiting), bicalutamide 150mg (Casodex™) reduces the risk of the cancer progressing by 42 per cent and reduces the risk of the cancer spreading to the bones by approximately 33 percent. In addition, in patients taking bicalutamide 150mg there was a significant delay in prostate-specific antigen (PSA) rise - a second indicator that the disease is under better control.

As with most cancers, prostate cancer patients have a better chance of survival if diagnosed early. Current standard treatment for early prostate cancer (i.e. surgery, radiotherapy or watchful waiting) is not always successful, as there is often disease recurrence or progression. The growth of prostate cancer is known to be stimulated by the male (androgenic) hormone, testosterone, and therefore the early use of an anti-androgen, in addition to standard treatment, could improve the outlook for men with prostate cancer. A similar approach has proved very successful in the treatment of breast cancer, where the use of tamoxifen (Nolvadex®, an anti-estrogen), in addition to standard treatment, has been shown to improve the survival of women with early disease.

"Progression of prostate cancer is associated with a number of serious complications such as anaemia, urinary obstruction, kidney failure, severe pain and pathological fractures caused by bone metastases. I believe that these first promising results from the EPC Programme will offer real hope for prostate cancer patients as we are already able to show a significant reduction in the risk of disease progression," said Dr. Yves Fradet, Professor of Surgery/Urology and Chairman of the Department of Surgery at Laval University in Quebec, and a Principal Investigator in the EPC Programme. "These results, although requiring further follow-up to assess their impact on patients' survival, already provide hope to the patients."

"The EPC Programme results are very exciting and will undoubtedly trigger discussion around the role of adjuvant hormonal therapy in the treatment of early prostate cancer. Inevitably, there will be some reservation regarding the preliminary nature of the data, which does not yet include any information on survival," said Dr. Jack Barkin, Chief of Urology at Humber River Regional

Hospital in Toronto, Ontario. "Nonetheless, prolonging the time to clinical progression will result in significant benefits for patients with early prostate cancer, especially those at high risk of experiencing the morbidity associated with disease progression."

The data will be presented on June 27th, 2001 at the Canadian Urology Association (CUA) meeting in Toronto, Ontario. The data have already been submitted to the United Kingdom regulatory authorities and will be submitted to other regulatory authorities around the world during the course of 2001. The aim of such submissions is to provide clinicians and patients with an additional treatment option for localized and locally advanced prostate cancer.

The majority of side effects reported were predicted from the mode of action of the drug. Breast swelling and breast pain were the most frequent, but in the majority of patients, these were mild to moderate, frequently resolving or improving when therapy was withdrawn.

The EPC Programme involved a total of 8,113 men with localized and locally advanced prostate cancer and was carried out in Europe, North America, Scandinavia, South Africa, Australia, Israel and Mexico.(1) In Canada, 14 centers participated in the study and 318 patients were involved. Patients were randomized to receive bicalutamide 150mg once daily or placebo, in addition to standard care.

Despite an increase in public awareness and screening, prostate cancer does not have the same level of public recognition as other forms of cancer, such as breast cancer. Yet, it is the second most commonly diagnosed male cancer in Canada, as well as many western countries, after lung cancer. According to the National Cancer Institute of Canada, it is estimated that nearly 17,800 new cases of prostate cancer will be diagnosed and 4,300 men will die from the disease in Canada during 2001.(2)

References:

1. WA See, D McLeod, P Iversen, M Wirth. The Bicalutamide Early Prostate Cancer Program. Demography. Urol Onc 2001;vol6: 43-47.

2. National Cancer Institute of Canada, Canadian Cancer Statistics 2001, Toronto, Canada

SOURCE: AstraZeneca Canada

Early Antibiotics Prevent Lyme Disease After Deer Tick Bite

A DGReview of :"Prophylaxis with Single-Dose Doxycycline for the Prevention of Lyme Disease after an Ixodes scapularis Tick Bite"

New England Journal of Medicine (NEJM) 06/13/2001 By Anne MacLennan

A single 200-mg dose of doxycycline within 72 hours after a deer tick bite can prevent development of Lyme disease.

This is the controversial finding of a multicentre study in an area of the United States where the incidence of Lyme disease is among the highest in the world.

Study results have been published online by the New England Journal of Medicine in advance of the formal publication date and because of their potential important in treatment.

However, findings also confirm that even in the study area, Westchester County, New York, where the disease is hyperendemic, risk of Lyme disease after a deer tick bite is low at 3.2 percent overall among recipients.

This study also confirms experimental evidence that ticks must become at least partially engorged with blood, i.e. they must feed for many hours, before Borrelia burgdorferi is transmitted.

The report comes on the heels of a recent recommendation from the Infectious Diseases Society of America that people bitten by deer ticks (Ixodes scapularis) should not routinely receive antimicrobial chemoprophylaxis.

This recommendation was based on risk and consequences of Lyme disease, as well as costs, adverse effects and efficacy of antimicrobial Prophylaxis.

Participants in this double-blind, placebo-controlled trial of treatment with a single 200-mg dose of doxycycline were 482 people who had removed attached I. scapularis ticks from their bodies within the previous 72 hours.

At baseline, and at three weeks and six weeks, researchers interviewed and examined the patients and did serum antibody tests as well as blood cultures for Borrelia burgdorferi.

Entomologists confirmed the species of the ticks and classified them according to sex, stage and degree of engorgement - a sophisticated assessment not normally available in clinical practice.

Erythema migrans developed at the tick bite site in a significantly smaller proportion of subjects on doxycycline than on placebo.

None of the patients developed objective extracutaneous signs of Lyme disease, and there were no asymptomatic seroconversions.

Treatment with doxycycline was linked with more frequent adverse effects (in 30.1 percent of those on doxycycline versus 11.1 percent of those on placebo). These effects were primarily nausea and vomiting.

Erythema migrans was also found to develop more frequently after untreated bites from nymphal ticks than after bites from adult female ticks and, particularly, after bites from nymphal ticks that were at least partially engorged with blood.

Who should receive doxycycline for tick bite? The treatment may be reasonable for people bitten by ticks in areas where incidence of the disease is high and the tick is a nymphal deer tick at least partially engorged with blood.

However, in the far more common circumstances in which the bite occurs in an area where the disease incidence is low, in which the tick is not a nymphal deer tick or is not at least partially engorged, risk of disease is likely to be so low that this treatment is not indicated.

In 1999, 92 percent of all reported cases of the disease in the US occurred in just nine states. However, in most areas of the country, and indeed even in many areas of these nine states, risk of Lyme disease is very low.

Indeed, most tick bites in the United States are from species that do not transmit Lyme disease.

In Europe and Asia, both the species of bacteria that cause Lyme disease and the ticks that are vectors are different from those in the US.

N Engl J Med 12 June 2001. "Prophylaxis with Single-Dose Doxycycline for the Prevention of Lyme Disease after an Ixodes scapularis Tick Bite"

Source:		NIH/National Institute Of Allergy And Infectious Diseases (http://www.niaid.nih.gov/)

Date:		Posted 6/21/2001

NIAID Collaboration Yields New Test For Lyme Disease

A new test developed with funding from the National Institute of Allergy and Infectious Diseases (NIAID) has been shown to be highly accurate and sensitive for detecting antibodies to Lyme disease. Produced by Immunetics, Inc. of Cambridge, Massachusetts, the new assay recently won approval from the Food and Drug Administration (FDA) for use as a diagnostic test for Lyme disease.

It is the first diagnostic tool to use a synthetic product called C6, a hybrid chemical marker based on components derived from the surface of Borrelia burgdorferi, the tick-borne bacterium that causes Lyme disease. The C6 test is sensitive only to antibodies generated during an active infection.

Lyme disease can be difficult to diagnose, especially in later stages of infection when an individual’s antibodies can fall to very low levels. Laboratory testing showed the C6 approach resulted in a high rate of sensitivity to antibodies from both the early and late stages of Lyme disease. The kit also resulted in fewer false positive readings when compared with current screening methods. Significantly, no false positive readings were obtained when the kit was used to test people who had previously received Lymerix®, the Lyme disease vaccine. Another advantage is the test’s ability to detect antibodies specific to both U.S. and European strains of Borrelia.

“The C6 test is the result of years of collaboration in an ongoing effort to improve our ability to diagnose Lyme disease,” explains microbiologist Phillip Baker, Ph.D., NIAID’s Lyme disease program officer. “This new approach is an important first step in that direction.”

NIAID is a component of the National Institutes of Health (NIH). NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, tuberculosis, malaria, autoimmune disorders, asthma and allergies.

Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

The National Institute of Allergy and Infectious Diseases is a component of the National Institutes of Health, U.S. Department of Health and Human Services

Title: Fruit, Vegetables Do Matter Against Heart Disease, Says Large, Long-Term Study

URL: http://www.annals.org/issues/v134n12/abs/200106190-00010.html

Ann Intern Med. 2001;134: 1106-1114. "The Effect of Fruit and Vegetable Intake on Risk for Coronary Heart Disease"

06/21/2001 08:03:46 AM

By Anne MacLennan

A large study has tied consumption of fruits and vegetables, particularly those rich in vitamin C and green leafy vegetables, to a protective effect against coronary heart disease.

Until now, data on the relationship have been sparse, although many constituents of fruits and vegetables are known to reduce risk for coronary heart disease.

This was a prospective cohort study set within the large Nurses' Health Study and Health Professionals' Follow-up Study in the United States.

Kaumudi J Joshipura and colleagues from Harvard School of Public Health, Harvard School of Dental Medicine, Channing Laboratory, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts did the research.

Participants were 84,251 women aged 34 years to 59 years who were followed for 14 years and 42,148 men aged 40 years to 75 years who were followed for eight years.

All of the participants were free of diagnosed cardiovascular disease, cancer and diabetes at baseline.

As the main outcome measure, researchers used incidence of nonfatal myocardial infarction or fatal coronary heart disease (1,127 cases in women and 1,063 in men).

Diet was assessed by food-frequency questionnaires.

Once researchers took standard cardiovascular risk factors into account, people in the highest quintile of fruit and vegetable consumption had a relative risk for coronary heart disease of 0.80 versus those in the lowest quintile.

Indeed, each one-serving/day increase in fruit or vegetable intake was linked with a four percent lower risk for coronary heart disease.

Green leafy vegetables and vitamin C-rich fruits and vegetables contributed most significantly to the apparent protective effect of total fruit and vegetable intake.

http://www.annals.org/issues/v134n12/abs/200106190-00010.html

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Diet Linked to One in Three Cancers(from Yahoo New)

By Ray Dunne

LONDON (Reuters Health) - Almost one in three cancers could be prevented through healthier eating, a major international conference heard this week.

Researchers making presentations at the European Conference on Nutrition and Cancer in Lyon, France, linked thousands of cases of cancer in the western world to poor diet and a lack of exercise.

Conference attendees were also told of the preliminary findings of one of the world's largest studies investigating the relationship between the disease and what people eat.

The European Prospective Investigation into Cancer and Nutrition (EPIC)--one of the biggest in terms of individual data--has confirmed many previous studies showing that some food can increase the risks of cancer while others can have a protective effect on the human body.

However, it has also provided some new ideas and raised doubts about previously long-held theories.

The study, which is looking at the diets of more than 500,000 people from nine European countries, has confirmed once again that eating fruit and vegetables can ward off the disease, in particular colon and rectal cancer.

However, it casts doubts on the protective effects of fruit and vegetables on other cancers. For instance, the study found no evidence to suggest they can ward off cancers of the stomach and lungs.

``We do confirm that the consumption of fruit and vegetables reduces the risk of colorectal cancer and cancers of the mouth, pharynx and oesophagus,'' Dr. Elio Riboli, one of the organisers of the conference and one of those heading up the study, told Reuters Health.

``But we were surprised not to find at this early stage a clear protection for cancer of the stomach and lungs...for the time being the protection for lung and stomach cancer is a little weaker than we expected,'' he added.

The preliminary results have also raised questions about the long-held belief that eating red meat can increase the risk of cancer.

``For years there has been a fear that red meat, particularly beef, lamb and pork, could increase the risk of colorectal cancer,'' said Riboli. ``We have been looking very closely at this issue and the results don't support that. We cannot exclude a 10% to 15% increase for heavy consumption of meat, but the risk is not as we may have thought maybe 10 years ago.''

Riboli said the study would now examine the effects of different meats. ``This is interesting because it is the first time a large study has made a clear separation between processed and fresh meat. Previously, we were only concerned with total meat consumption.''

He added, ``We are now looking into the different types of meat and why processed meat may be a greater risk than fresh meat and to see what is in processed meat that may increase the risks.''

The study also highlights the long-established risks of alcohol and tobacco. Its latest findings suggest that smoking more than a pack of cigarettes each day can increase the risk of cancer by eight times.

Similarly, drinking a bottle of wine every day can boost the chances of getting the disease by nine times.

But the study found that excessive smoking and drinking combined can increase the risks by 50 times.

Riboli acknowledged that the findings could prove confusing for patients who want to change their diet to protect against cancer.

``From the point of view of advice, one can only have one diet and it is better that the diet is globally healthy rather than aimed at just one particular cancer. It has to take into account other diseases, such as cardiovascular disease. It should not be focused on just one particular cancer but on health generally,'' he said.

``We continue to recommend that people have a diet which has a little bit of everything but a lot fruit and vegetables and not necessarily a vegetarian diet, that they eat dairy products and remain physically active, don't smoke and drink only in moderation,'' the researcher advised.

The study, which is ongoing, is not due to finish until at least 2003. But the research team is planning to publish a scientific paper examining the links between cancer and food in 2002.

High Fiber Diet Can Cut Cancer Risk by 40 Percent-Study

from i

Updated: Sat, Jun 23 6:34 AM EDT

LONDON (Reuters) - A high fiber diet can slash the risk of developing deadly cancers by as much as 40 percent, scientists said Saturday.

Results from the biggest ever study into diet and cancer involving 400,000 people from nine countries, presented at an international conference in France, showed fiber was particularly important in reducing cancer of the colon and rectum.

"These are the first positive results for the benefits of fiber from such a large group. We placed 400,000 people on the study into five sets according to their consumption of fiber," Professor Sheila Bingham of the Dunn Human Nutrition Unit at Cambridge University said in a statement released in London.

"The group eating the most fiber reduced their risk of colorectal cancer by as much as 40 percent," she added.

The findings were part of the EPIC (European Prospective Investigation of Cancer and Nutrition) that was reported at the European Conference on Nutrition and Care in Lyon, France.

Medical experts believe up to 30 percent of all cancers in the developed world are associated with nutritional factors and could be avoided by better-balanced diets.

The EPIC study, which began 15 years ago, also showed a decreased chance of developing colon cancer in people eating lots of fish, but a raised risk in those consuming large amounts of preserved meats such as ham, bacon and salami.

People are advised to eat five portions of fruit and vegetables a day to achieve optimum health and avoid cancer.

Professor Nick Day said the landmark study should set the record straight on diet and cancer.

"There have been reports recently that appear to suggest fruit and vegetable consumption isn't important in reducing the risk of colorectal cancer," Day said.

"This wide-ranging study is likely to give us a much truer picture of the links between cancer and diet," he added.

The EPIC study also showed that people who smoke a packet of cigarettes a day and drink more than a bottle of wine are 50 times more likely to suffer from throat cancers.

Eating poultry did not increase the risk of cancer and may have a protective effect, according to the report.

"These finding are important because of the sheer scope of the EPIC study. They put fiber firmly back on the menu as an important part of a healthy diet," said Professor Gordon McVie, the director general of the Cancer Research Campaign, which sponsored Bingham's research.

The European Conference on Nutrition and Cancer, which began Thursday, is looking at the impact of different types of food on the disease.

Plant Hormones Form Basis of New Anti-Cancer Drugs

Updated: Wed, May 23 7:29 AM EDT

By Patricia Reaney

LONDON (Reuters) - A hormone used by plants to control their growth is being harnessed by British researchers to develop new targeted treatments for cancer, researchers said on Wednesday.

Plants need the hormone, called indole acetic acid (IAA), to bend shoots toward sunlight to help cuttings grow roots. Scientists at the Cancer Research Campaign, a leading scientific charity, are using fragments of IAA to kill cancer cells.

The hormone, which is produced by most plants, is harmless to humans. But, in early laboratory studies when scientists used bits of it and coupled them with an enzyme, it produced toxic by-products that destroyed cancerous tumors without harming healthy cells. "The fragmented molecule is only released in the tumor," Professor Peter Wardman told a news conference.

By targeting only the cancerous cells synthetic drugs based on IAA, called prodrugs, would be highly effective in killing the cancerous cells and would not produce side effects such as hair loss and nausea like conventional chemotherapy drugs.

"We're really excited that a common or garden plant hormone could fulfil one of the ultimate aims of cancer research, by providing a drug that only attacks cells and leaves the rest of the body untouched," Wardman, a scientist at the Gray Cancer Institutes in southern England, explained.

In laboratory studies of cell cultures Wardman and his colleagues used an enzyme called peroxidase, which is derived from the horseradish plant, to trigger the release of the toxic by-products of IAA to destroy tumors.

Early results show the treatment, which has been patented by the CRC, killed 99 percent of the cancerous cells and with different types of cancer. Scientists said tests will now have to be done on animals and humans.

"Nearly all of the cells are killed with a single treatment," said Wardman.

The scientists used the horseradish enzyme because it is cheap and well studied. It breaks up IAA into smaller chemicals which react with other molecules in the body to produce the toxins.

To direct the toxins only to the