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Clinical Notes

doi: 10.1097/01.COT.0000294281.49389.4a
Clinical Notes
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Garlic Ingredient Knocks Out Antibiotic-Resistant Microbes

Dangerous multidrug-resistant microbes might be controlled by one of the biologically active ingredients in garlic—allicin.

In presentations in December at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), a meeting sponsored by the American Society of Microbiology, researchers demonstrated that in the laboratory, allicin can destroy methicillin-resistant Staphylococcus aureus (MRSA) and inhibit growth of vancomycin-resistant enterococci (VRE). Both are threats to patients recovering from surgery or open infection, generally in hospital settings, but also those undergoing chemotherapy, abdominal or other surgery, or who are otherwise immunosuppressed.

Doctors cautioned, however, that it is still far too early to be talking about “Allicin Wonderdrug.”

“What happens in a test tube may not occur when it is used in humans,” cautioned Jaya Prakash, MD, Chairperson of the Department of Pathology, Microbiology, and Public Health at National University of Health Sciences in Lombard, Illinois.

However, what Ronald Cutler, PhD, Senior Lecturer in Microbiology at the University of East London, UK, said, certainly makes researchers take notice: “Allicin simply blows enormous holes through MRSA,” he remarked. Dr. Cutler has formulated allicin into skin products such as creams and soaps and has achieved success in destroying the microbe in laboratory tests.

He has also tested the cream on healthy volunteers—including himself—and said there have been “absolutely no adverse reactions.” Dr. Cutler and his commercial venture, named Allicin International Limited, are now beginning human testing with the allicin cream on patients with stubborn skin infections caused by MRSA.

Dr. Prakash is experimenting with allicin in thwarting VRE. “We have shown that we can inhibit the growth of these bacteria with allicin. Some of the isolates are more stubborn than others,” she said, but at 150 micrograms of allicin the bacteria cannot proliferate.

Dr. Prakash noted that people can ingest about 25 grams a day of garlic without ill effects, and that garlic typically contains about 15 milligrams of allicin, which is about 100 times more than what she used to control VRE.

In Dr. Prakash's study, allicin was tested against two normal strains of Enterococci fecalis and 24 vancomycin-resistant strains of E. fecalis. The allicin concentrations stopped growth of the microbes within four hours.

Dr. Cutler said concentrations of allicin at levels of 32 parts per million in a liquid or cream formulation were sufficient to inhibit MRSA. The cream he tested on himself contained 500 parts per million of allicin. He added that allicin appears to be effective against MRSA that is resistant to the antibiotic mupricin, frequently used to fight the infection.

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FDA Approves PathVysion Breast Cancer Test for Herceptin Response

The Vysis PathVysion HER-2 DNA Probe Kit to detect the HER-2/neu gene in breast cancer patients has received approval from the Food and Drug Administration for use in identifying women with metastatic breast cancer who could benefit from Herceptin therapy. The manufacturer, Vysis, is a subsidiary of Abbot Laboratories.

The presence of multiple copies of the HER-2 gene plays a pivotal role in the rapid growth of tumor cells in 25 to 30 percent of breast cancer patients. Breast cancer patients who are positive for HER-2 typically experience rapid tumor growth and resistance to therapy and have a poorer prognosis. Determination of HER-2 status is a critical tool for selecting therapeutic options, because certain breast cancer treatments are more appropriate when multiple copies of the gene are found.

“Gene amplification, as determined by fluorescence in situ hybridization (FISH), is a clinically meaningful measure associated with poor prognosis and predictive of therapeutic response,” Michael Press, MD, PhD, Professor Harold E. Lee Chair for Cancer Research in the Department of Pathology at Norris Comprehensive Cancer Center at the University of Southern California, explained in a news release from Abbott.

“The unique advantage of FISH is in its ability to target the much more stable DNA molecule within a patient's breast cancer tissue.”

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Malpractice Rates Up

Medical insurers are sharply raising their malpractice premiums, some by as much as 20 to 30 percent. Insurers blame a lethal combination of rising jury awards and settlements and a falling stock market for the increases.

In recent years, the insurers' financial strategy had been to keep prices artificially low in order to increase their market share, invest the proceeds in the stock market, and use the profits to subsidize the low rates. That once-successful approach has been sabotaged by the current bear market.

With jury awards now averaging more than $3 million and settlement agreements at an all-time high, insurers have been pinning their hopes for some relief onto a hotly debated tort reform provision in the Patients' Bill of Rights.

The principal impediment to passage of that legislation has been a fierce battle over medical liability. Insurers, and many Republicans want to cap awards for pain and suffering at $250,000. However, even if the provision should become law, the outlook is still bleak. The $250,000 limit is already on the books in California, but juries are getting around it by raising awards for other damages such as medical expenses and lost wages. Tort reform supporters say that a carefully written federal bill could get around this.

“We are on the verge of a national crisis,” said AMA President Richard F. Corlin, MD. “We are in the exact same position as we were during the crisis of the mid-'70s, with premium rates going up and carriers pulling out. In some respects the environment is even worse now because rises in premium costs cannot be passed along to patients. It is an impossible situation.”

Dr. Corlin called for unity among the AMA and specialty societies to deal with the situation. “Physicians must be willing to coordinate their activities and to invest in themselves,” he said. “We have the armies, but we need the ammunition. We can't beat the trial lawyers, who are writing out thousand-dollar checks with checks for $25 or $50. It won't do. This is going to be a tough fight.”

The AMA also wants tort reform and the Patients' Bill of Rights to be introduced separately. It argues that tort reform, which has never passed in the Senate, would be a poison pill as far as passage of the Bill of Rights.

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Hospital Readiness for Attack

After 15 years of managed care in which cost cutting became a major priority, America's hospitals are nowhere close to a state of readiness should the country be struck by a full-scale bioterrorism attack. That is the consensus of public health experts, who blame cutbacks in drug and equipment inventories, fewer beds, and reduced emergency room capacity, plus a general lack of planning for such an eventuality.

Moreover, many hospitals have been closed entirely by for-profit chains and there is a serious and growing shortage of nurses and pharmacists. Given all this, it is no wonder hospital officials around the country are scrambling to prepare for an event that is no longer unthinkable.

“Because of all the cutbacks, surge capacity is gone, said Stuart B. Weiss, MD, Director of Disaster Preparedness at St. Barnabas Medical Center in Livingston, NJ. “Most hospitals have no ability to handle a sudden, large patient influx. In the short term, they can manage to a certain point, say a 20 percent increase in the emergency department, but they cannot manage on a sustained basis.”

He cited just-in-time pharmaceutical delivery, the present and growing nursing shortage, and limited inventory as major impediments to attaining a state of readiness at what will inevitably be the first line of defense.

“In a disaster, all immediate response is local; it generally takes 12 to 14 hours for outside help to respond.” he explained. “In the World Trade Center disaster, the early response was all municipal. It took some time for support teams to arrive.”

It is for this reason that Dr. Weiss says hospitals must plan to support the first surge of patients themselves for 12 to 24 hours. “Because it takes the federal government at least 24 hours to get up to speed, a good local set-up is imperative,” he said. It is also costly. “Stocks of pharmaceuticals, supplies, and equipment will all have to be beefed up,” he said. “It's a very expensive proposition, and it's going to take state and federal help to make it happen.”

“It's not a question of whether there will be more terrorist attacks, it's the where and when that are uncertain,” Dr. Weiss said.

At St. Barnabas, the focus is on mobility and breadth. “We have equipment on wheels and trailers ready to go wherever in the state they are needed. Moreover, we take an all-hazards approach. We are looking at biochemical attack, ice storms, floods, and explosives. Readiness must be multipurpose”

Until recently, hospitals did not receive funding for disaster preparedness. “The money went to emergency medical services, fire departments, and other municipal services, Dr. Weiss noted. “Hospitals were asked to bear the burden on their own, and CEOs had to choose between keeping the CT scanner going and buying drugs versus bioterrorist attacks. Many chose to do things that were more immediately useful.” He was cautiously optimistic that Congress would soon pass legislation to directly fund hospitals.

“Despite the current focus on bioterrorism, the number one threat is explosion, using cars, trucks, and planes,” Dr. Weiss warned.

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Heat Therapy for Liver Cancer

Radiofrequency ablation, traditionally used to correct heart arrhythmias, received FDA approval for use against inoperable liver cancer last year. Since then, researchers at the University of Florida's Shands Cancer Center have used the technique on nearly 100 patients and report that it is easier, cheaper, and less risky than the standard therapy for inoperable tumors of cryotherapy.

“An unfortunate byproduct of cryotherapy is that it causes some patients to develop a form of shock, having to do with the fact that circulating hormone levels in the body increase and cause a bad systemic reaction,” said Scott Schell, MD, Assistant Professor of Surgery and Molecular Genetics and Microbiology. Heat, on the other hand, does not trigger that kind of hormone cascade.

Dr. Schell also noted that unlike cryotherapy, which is cumbersome, expensive, and cannot be performed laparoscopically, radiofrequency ablation uses a small needle to deploy an antenna into the center of the tumor. “Through this antenna, we deliver radio energy that acts to kill the tumor cells by heating them up so hot that proteins are destroyed, similar to the way an egg white coagulates during cooking,” he explained. “These tumor cells are basically cooked to death.”

In their most recent study, University of Florida surgeons evaluated nine patients aged 40 to 85 who had inoperable liver tumors. Blood levels of inflammatory hormones were measured during radiofrequency ablation and 48 hours later when the cascade of hormones typically peaks.

“Remarkably, there was no significant elevation in hormone levels,” Dr. Schell reported at the most recent annual meeting of the Southeastern Surgical Congress. “We have seen quite plainly why these people are not getting sick. These findings are novel and have never before been reported in patients.”

Dr. Schell also reported that the risk of adverse effects or deaths from the procedure is lower, while the results appear to be equivalent or even superior to those seen with cryotherapy or liver surgery.

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Prolonged Responses in Refractory/Relapsing Low-Grade NHL with MabThera + IF

Sequential immunotherapy with MabTheraTM, a chimeric anti-CD20 monoclonal antibody, and recombinant interferon alpha can prolong therapeutic responses in patients with refractory/relapsing low-grade non-Hodgkin's lymphoma (NHL), according to data presented at the most recent annual meeting of the International Society for Experimental Hematology.

Andre Bosly, MD, Director of the Department of Hematology at the Catholic University of Louvain and Mont-Godinne University Hospital in Yvoir, Belgium, reported for the Belgian Hematologic Society, calling the findings an important advance in the management of such patients, who historically have had a very poor prognosis.

Earlier studies had shown that MabThera can induce objective responses persisting for a median of 13 months in about one half of patients with indolent refractory/relapsing NHL, Dr. Bosly said.

In an attempt to increase this response rate, a 17-center Belgian consortium explored the potential of using interferon alpha for prolonging the duration of the MabThera-initiated anti-NHL response.

In the single-arm Phase II study, 70 patients with advanced NHL, who had failed to respond to at least one prior systemic chemotherapy regimen, were treated with MabThera, followed two weeks after the last MabThera infusion by interferon alpha. The choice of interferon was based on the agent's known antitumor and apoptosis-inducing activities, Professor Bosly said in an interview.

Response and survival rates were analyzed on an intent-to-treat basis. The addition of interferon failed to alter the rate of objective response (49% vs 41%), but did prolong the duration of response significantly (20 vs 13 months).

At the 18-month follow-up, the median time to progression had not yet been reached for complete responders. The median duration of overall objective response (complete and partial responses) was 20 months.

Asked whether the addition of interferon might have retarded disease progression in patients who had failed to achieve an objective response, Dr. Bosly replied, “We do not know, since patients whose disease progressed on MabThera did not go on to receive interferon therapy.”

He speculated that the probable mechanism of action whereby interferon potentiates the action of anti-CD20 to prolong objective response of NHL to MabThera was due to apoptosis. “Serious adverse events during MabThera therapy with or without interferon alpha developed in 13 and 23 percent of patients, respectively,” he said. “However, these adverse events were reversible, and no toxic deaths occurred.”

Sequential administration of MabThera and interferon alpha may increase the rate of complete responses and prolong response in patients with advanced indolent NHLs, he remarked.

“The take-home message is that the combination of MabThera and interferon alpha is feasible in NHL, but should be confirmed in a large randomized trial. Furthermore, we should explore whether interferon alpha maintenance for 12 to 18 months rather than six months might further prolong remissions following MabThera.

Howard Ozer, MD, PhD, Director of the Oklahoma University Cancer Center in Oklahoma City, commented that it was interesting that Dr. Bosly ascribes the beneficial effect to enhanced apoptosis, something that his own group has also been looking at.

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Maine City Votes for Universal Health Care

An old saying about the outcome of presidential elections is: “As Maine goes, so goes the nation.” Supporters of universal health care are hoping this adage will apply to their cause as well. Last Election Day, voters in Portland passed a referendum calling for a government-run program to provide health insurance for each and every citizen in the state.

Admittedly the referendum was non-binding and the vote, 52 to 48 percent, was not exactly overwhelming. Nevertheless, it passed in the face of a hugely expensive campaign mounted by opponents of the plan and led by Anthem Blue Cross and Blue Shield, the state's principal health insurer.

A blizzard of newspaper, radio, and TV ads warned of long waits, health care rationing, higher taxes, and a cumbersome government bureaucracy should such a plan go into effect. In contrast, proponents of the plan spent only about $25,000.

The vote is just the opening skirmish in a longer campaign. The state legislature will be taking up the matter after an ad hoc board issues a report and recommendations in March. With more people losing their jobs and their health insurance, while others struggle to pay their rising premiums, the real battle lies ahead—and not just in Maine.

© 2002 Lippincott Williams & Wilkins, Inc.
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