Drug Resistant Bacteria-Part I

Because this topic has come into the limelight to such a great extent, and because this particular article has become so lengthy, we at theruibins are now starting a Part III for this topic. Therefore for the latest developments in this area please go to Drug Resistant Bacteria-Part III 

(9/27/08)- Most of this article has contained information about the drug resistant bacteria Methicillin-resistant Staphylococcus aureus (MRSA), but now another superbug, Clostridium difficile-C.diff is also becoming a major problem for epidemiologists. C.diff infections in hospitals can lead to severe diarrhea, ruptured colons, perforated bowels, kidney failure, blood poisoning and death.

The Centers for Disease Control and Prevention estimates there are 500,000 cases of C.diff infections annually in the United States, contributing to between 15,000 to 30,000 deaths annually. That's up from about 150,000 cases in 2001.

Many patients get C. diff infections as an unintended consequence of taking antibiotics for other illnesses. The bacteria normally found in a person's intestines help keep C. diff under control, allowing the bug to live in the gut without necessarily causing illness. When given an antibiotic however, both the bad and the good bacteria are suppressed, allowing drug resistant C.diff to grow out of control.

Many hospitals now have special rules requiring staff to wash their hands with antibacterial soap when dealing with C. diff patients.

C. diff was first recognized in the 1970s, when it was readily treatable. The more virulent strain was first identified at the University of Pittsburgh Medical Center in 2000, killing 18 patients. By the year 2004 this strain of drug resistant bacteria had spread throughout the world.

(9/11/08)- Medicare will stop paying hospitals for preventable infections that patients contract while under the facilities care. As we note in our item dated 10/29/07 below: " Just 4 states require the publishing of infection rates in hospitals within their communities, and only Pennsylvania breaks out different types of infections. Please see our item dated 7/21/07 below for more on the Pennsylvania matter. The 4 states are Missouri, Vermont, Florida and Pennsylvania.

A Web site from Consumers Union, has links to reports from each of those states according to Lisa McGiffert, the director of Stop Hospital Infection Campaign."

Many hospitals are turning to antibiotic SWAT teams to deal with this drug resistant bacteria problem. The team monitors the use of antibiotics within the medical facility and restricts prescriptions of specific drugs when they become less effective in fighting infections.

Estimates are running as high as two million patients acquiring bacterial infections while in medical facilities with an estimated 90,000 of them dying as a result of these infections.

The two leading hospital purchasing groups are mounting new campaigns to reduce the use of antibiotics. VHA Inc., an alliance of more than 1,4000 nonprofit hospitals, has launched a "Bugs and Drugs " program to help member institutions identify and manage this problem.

Premier Inc., which represents more than 2,000 hospitals is urging members to adopt anti-microbial stewardship programs and offering an electronic data-tracking system to help monitor the use of certain drugs.

The National Quality Forum, the leading government advisory body on health-care quality standards, plans to issue revised safety standards for hospitals shortly, that include a new requirement that hospitals implement anti-microbial stewardship programs, according to Charles Denham, co-chairman of its Safe Practices group.

(9/5/08)- The California state Senate, by a vote of 33 to 4 passed the Medical Facility Infection Control and Prevention Act (SB 1058) which will require the states' health-care facilities to screen certain incoming patients for Methicillin-resistant Staphylococcus aureus (MRSA) within 24 hours of admission.

The state's House unanimously passed the same bill on August 20th and the Governor has until the end of this month to sign it. The state is presently engaged in a budget battle, since California is running about a $15 billion deficit, but there are enough votes in both houses to ensure passage of the act.

The required MRSA testing would be limited to patients scheduled for inpatient surgery who have a medical condition that makes them susceptible to infection; a patient re-admitted to a hospital within 30 days of discharge; a patient being admitted to the burn or intensive care units; a patient receiving an inpatient dialysis treatment; or a patient being transferred from a skilled nursing facility.

Pennsylvania, Illinois and New Jersey are the only states to date that have passed laws requiring screening of at least high-risk patients admitted to hospitals. California and New York are two of 6 other states currently considering legislation to reduce the incidence of MRSA through screening of newly admitted patients.

(4/3/08)- The Copper Development Association, a trade group for copper companies, said that federal regulators had approved its application to market a group of copper alloys, including brass and bronze, that are capable of killing bacteria and microbes effectively enough to protect human health.

Copper ions can penetrate the cell walls of microbes and disrupt reproduction and other cell functions. The approval is the first time that the Environmental Protection Agency (EPA) has allowed health claims to be attached to a solid anti-microbial material rather than a liquid or aerosol disinfectant.

The EPA regulates anti-microbial products not applied directly to the body under the laws intended to control agricultural pesticides.

Tests of the products showed a 99.9% kill rate within two hours against the leading biotic-resistant bacteria now plaguing hospitals, according to Harold T. Michels, senior vice president for technology and technical services at the trade group.

Tests are underway to determine if copper bed rails, arm rests and other hospital fixtures can reduce the number of bacteria in hospitals.

(3/17/08)- An article written by Andrew Pollack, that appeared in the March 4th edition of the New York Times entitled "A Bug Rises and With It A Company" discussed one of the rapid molecular-diagnostic tests that we mentioned in our item dated 2/21/08 below. The testing device discussed in the article is made by Cephid, a biotechnology company in Silicon Valley.

Cephid's only competitor in rapid genetic testing for MRSA is Becton, Dickinson, but other companies including Roche, Gen-Probe, Third Wave and Qiagen are expected to gain approval for their devices within the next year or so.

There are currently only four states- Illinois, Minnesota, New Jersey and Pennsylvania that mandate that hospitals screen at least certain patients at the time of their admission. Before the introduction of the DNA testing devices, hospitals detected MRSA by growing the nasal sample in cultures, and even though this is cheaper than the DNA methodology, it takes several days before the results are known.

Cephid's test can take as little as 72 minutes before the results are known. Hospitals must buy the company's GeneXpert machine, which costs about $30,000 to $150,000 depending on how many tests it can run at once. Each individual test cartridge is priced at $42.

Becton's competing machine starts at about $35,000 and each test costs $25. Cephid's test does not require the same level of expertise as does Becton's system. Cephid's machine can test patients one at a time, while Becton's machine is geared more towards labs, where several specimens are analyzed at the same time.

A recent article in the Wall St. Journal, that was written by Laura Landro, entitled" Hidden Hazard: Hospitals Target Lurking Latex" pointed out another danger that patient's face when exposed to medical treatment-namely latex allergy reactions. The article went on to detail how hospital and medical facilities are trying to eliminate latex products from medical equipment.

Premier Inc., the large hospital purchasing cooperative, "is issuing the group-purchasing industry's most comprehensive latex-free catalog, featuring 16,675 items, ranging from urinary-tract catheters to blood-pressure cuffs, suction devices and syringes" according to the article.

"Johns Hopkins Hospital last month announced plans to end the use of all latex gloves and almost all latex medical products." The hospital is working with Yulex Inc., a Maricopa, Ariz., based company, which has the exclusive license o a patent from the U.S. Department of Agriculture to make a latex substitute from guayule, a desert plant in the Southwest that doesn't contain the allergy-triggering-protein.

"Allergic reactions can be mild, such as a skin rash or irritation, but can also include respiratory distress and severe reaction know as anaphylactic shock, which can leas to a life-threatening drop in blood pressure and death."

The FDA now requires all products containing latex to be labeled, but hospital administrators say labeling practices are all over the place, so that more work has to be done in this area.

(2/21/08)- The FDA has approved two first-of-their-kind rapid molecular-diagnostic tests that use DNA technology to speed the testing for harmful bacteria that may be present in hospital patients. By catching those patients who are just admitted to a hospital, the medical profession can sharply reduce the risk of the drug resistant type of bacteria from spreading to other patients in the facility.

The tests are covered by most patient's insurers, but they cost about $30 per test, as opposed to the $3 cost of the traditional cell culture type of test. This new type of test can be back with the results in two hours versus the much longer time frame needed for the cell-culture type of test.

One of the tests just approved by the FDA is a blood test that diagnose the patient for methicillin-resistant Staphylococcus aureus (MRSA) within two hours. The other test is one that can distinguish between 12 viruses and strains, including those responsible for common forms of the flu.

The DNA-based molecular technologies behind these tests have been around for years, but their complexity meant that they could only be used in specialized institutions. By using the generic information garnered from the test, it determines the level of resistance to any antibiotic. The tests may even be able to identify some strains that can't be grown, and therefore couldn't be detected under the microscope.

(12/14/07)- Thirty-four of every 1000 U.S. hospital inpatients are infected with methicillin-resistant Staphylococcus aureus (MRSA), according to a survey of more than 1200 hospitals (21% of U.S. hospitals). They found a total of 7,944 affected patients, with 63% having blood, pneumonia or urinary tract MRSA infections. (American Medical News, a publication of the AMA. July 9, 2007)

A special education teacher in a public school in Maryland passed away Sunday December 9th, from complications that resulted from her being infected by a drug-resistant bacterium. Merry King, the teacher had worked at the Herbert Hoover Middle School in Potomac Maryland for two of the last three years.

 Ms. King's classroom was sanitized as a precaution and communal areas of the school were also sanitized with a bleach solution according to a spokeswoman for the Montgomery school.

(11/18/07)- A new unusually virulent form of a virus that can cause colds and other respiratory infections has caused 10 deaths in the last 18 months according to officials from the Centers for Disease Prevention and Control. The new virus Ad14 (for adenovirus serotype 14) has caused at least 140 illnesses in New York, Oregon, Texas and Washington.

The illness made headlines in Texas in September, when a 19-year-old Air Force trainee at Lackland Air Force Base in San Antonio died after he had contacted the disease.

(10/29/07)- The recent death of a 14-year-old boy in Brooklyn, N.Y, and of another young person in Newark, N.J. that were caused by methicilin-resistant Staphyloccuc aureus. (MRSA) brought to the forefront the lack of publicly available information on the spread of the disease.

Health officials in New York continue to investigate the death of the boy who was attending Intermediate School 211 in the Canarsie section of the borough. The school sent out a letter informing parents that a student had died from the infection, and that the school had been thoroughly cleaned. The letter also said that hand washing was the best way to prevent the disease.

The proper way to wash one's hands to help prevent the bacteria from spreading is by washing your hands for at least 15 seconds under a hot water faucet, and by rubbing soap vigorously to create enough friction to rub off contaminants. If you are using a gel to fight the bacteria, make sure the gel dries before you shake someone else's hand.

As we note in our item dated 10/21/07 below state school officials in three states have recently reported deaths of students in their states. They are in Miss., New Hampshire and Virginia. The CDC advises on its Web site that a decision about whether to close a school because of a communicable disease should be made by school officials or by local or state heath authorities.

Health authorities have been hampered in trying to gather data on MRSA because of the fact that doctors do not have to report cases of the bacterial infection occurring outside hospitals or nursing homes. As a result it is impossible to tell if the number of cases is increasing. For more information in how to try and prevent the spread of the bacteria, please go to the CDC site at

The New York City Board of Health is now considering whether or not to require the reporting of non-hospital cases of staph infections. In N.J. state education officials sent a memo to the superintendents of the state's 615 school districts asking them to report any individual MRSA cases to the Education Department.

Nineteen states have adopted laws in recent years requiring hospitals to report overall infection rates publicly, with more state likely now to pass similar type laws. Representative Tim Murphy of Pennsylvania said he would propose legislation requiring nationwide public reporting.

Just 4 states require the publishing of infection rates in hospitals within their communities, and only Pennsylvania breaks out different types of infections. Please see our item dated 7/21/07 below for more on the Pennsylvania matter. The 4 states are Missouri, Vermont, Florida and Pennsylvania.

A Web site from Consumers Union, has links to reports from each of those states according to Lisa McGiffert, the director of Stop Hospital Infection Campaign.

Pennsylvania will soon require hospitals to test high-risk patients, including those admitted from nursing homes. In August, New Jersey and Illinois adopted legislation requiring hospitals to identify patients carrying MRSA and isolate them, among other provisions.

(10/21/07)- The results of a recent study, whose authors worked for the Centers for Disease Control and Prevention estimated that nearly 19,000 people died in the United States after being infected with methicilin-resistant Staphyloccuc aureus. (MRSA). The results of the study were published recently in The Journal of the American Medical Association.

If this estimate is correct, it means that deaths from MRSA exceeds the number of deaths attributed to H.I.V.-AIDS, Parkinson's disease, emphysema or homicide each year. The data for the study came from nine different places and involved 84,360 patients who developed an invasive infection from the pathogen in 2005.

The study found that 27% of all invasive MRSAQ infections originated in hospitals, while 58% began outside a hospital , but in patients with some recent exposure to the health care system. The remaining 15% of invasive MRSA cases originate in the community without any apparent health care risk factor.

School officials in Miss., New Hampshire and Virginia reported student deaths within the past two weeks form the bacteria, while officials in at least four other states reported cases of students being infected.

Dr.R.Monina Klevens was the lead author of the study.

(7/21/07)- Last year, Pennsylvania reported 19,154 cases of hospital-acquired infections in 2005, generating nearly 400,000 additional patient days in the hospital and $3.5 billion in charges. The state recently detailed 175 hospital medical errors over a 30-month period, many of them classified as "wrong site surgeries."

(7/3/07)- The results of a recent study that was conducted by the Association for Professionals in Infection Control and Epidemiology (APIC) at 1200 health care facilities in the U.S indicated that 34 of every 1000 patients were infected with Methicilin-resistant staph aureus. (MRSA) MRSA now makes up more than 60% of hospital staph infections, up from 2% in the mid -1970s.

The FDC estimates that 126,000 people are hospitalized with MRSA infections each year and about 5,000 die from it. Many hospitals are now screening patients with new tests that can rapidly detect these bacteria. Although the tests are expensive, in that they may cost anywhere from $25 to $30 apiece they save money in the long run.

The FDA has approved rapid testing devices from Becton, Dickinson & Co., of Franklin Lakes, N.J. and Cephid, which is based in Sunnyvale, Calif.

(6/17/07)- About 2 million people catch bacterial infection in U.S. hospitals every year and about 90,000 of them die. That number represents an increase of almost sevenfold from what it was 10 years ago, as the problem of drug resistant bacteria continues to grow. Staphylococcus aureus continues to be the most common of the drug resistant bacteria.

Last month, an international team of 11 scientists, led by biologists at the Rockefeller University in New York City were able document the evolution of the mutations in the bacteria of a serious ill patient who came into an unnamed hospital with the staph infection.

Biologist Michael Mwangi and his colleagues analyzed the infection's genetic code as it changed in a series of blood samples taken during the patient's stay. Patient X died in October 2000, after a 12-week hospital stay. The result of the team's study was published in a recent copy of the National Academy of Sciences Journal.

At the time of the patient's admission to the hospital he was already infected with the staph infection, but it was treatable at that time. Every time the patient took his medicine the antibiotics killed the weakest bacteria in his bloodstream, but those bacteria that survived passed on their traits to the next generation of bacteria in the patient's body.

These resistant microbes accumulated 35 mutations, with each one altering a molecular sensor or production of a protein. Researchers than matched these gradual genetic changes to increasing levels of drug resistance.

During the patient's course of treatment the bacteria quickly developed stronger resistance to four antibiotics, including Vancomycin, the drug of last resort for intractable infections. The Rockefeller researchers believe that by better understanding the evolution of the mutations that occur in the bacteria will eventually lead to better treatment.

(1/5/07)- A federal report that was done in 2004 showed that, on average, U.S. patients in ICUs spent about half their time in the unit with central-line catheters. It is estimated that about 28,000 patients die each year from blood infections caused by these catheters. It is further estimated that treatment of patients as a result of these infections result in an additional cost of about $45,000 per patient.

A recent study that was conducted in Michigan hospitals showed that common sense and better hygiene practices could almost eliminate this problem. Peter Pronovost, lead author of the study, and medical director of the Center for Innovation in Quality Patient Care at Johns Hopkins University said, "We could practically eliminate this type of infection."

The steps include making sure doctors and nurses wash their hands and wear protective clothing. Central-line catheters deliver drugs and nutrition to patients through a vein in the neck, chest and groin.

Researchers examined Michigan hospitals that agreed to use the safety procedures in their ICUs. After strictly adhering to the practices, hospitals nearly eliminated catheter related blood infections. The results of the study were recently published in the Journal of Medicine.

In addition to practicing proper hygiene, such as disinfecting the catheter site, the hospitals in the study were instructed to remove unnecessary catheters more quickly and to avoid placing catheters in the femoral vein, which is near the groin and more susceptible to infections.

(8/23/06)- A study, which looked at patients treated in emergency rooms in 11 major cities, found that drug-resistant staph infections are present in 59% of skin and soft-tissue infections.

The results were posted in a recent article in the New England Journal of Medicine. The scary part of the study is that many of the infected patients had USA300, a virulent new form of methicillin resistant staphylococcus aureus (MRSA), which is transmitted from person to person in communities outside the hospital.

Community-associated MRSA has broken out among prisoners, intravenous-drug users, military trainees and athletes. Gregory Moran, an emergency-room physician at the Olive View-UCLA Medical Center, in Sylmar, Cal was the lead author of the study.

The study looked at 422 emergency-room patients in August 2004. MRSA was found in 249 of those patients. The USA300 strain was detected in 212 of the 218 patient tissue samples that were sent to the U.S. Centers for
Disease Control and Prevention for further testing.

(4/8/06)- It requires about 48 hours for the diagnostic tests to determine if a patient has been infected with drug-resistant bacteria. In the meantime, the infected individual could spread the bacteria to all those who the individual comes in contact with. Medical technology companies have been working on developing tests to speed up the diagnosis to a few hours instead of the two-day period it now takes.

One of the problems however is that the hardware for these new tests can cost between $35,000 to $50,000. The new test kits being developed cost between $20 to $30 as against the cost of the present test kits of $5.

Hospitals face the problem of having isolated space for patients who have been found to have drug-resistant staph infections. Its recently acquired GeneOhm unit makes Becton Dickinson's rapid test. The test process involves nasal swabs used to survey colonization rates. The company hopes to bring out future tests to detect MRSA in infected blood and tissue.

The MRSA test is also marketed by Cepheld of Sunnyvale, California, which also sells the hardware- a $34,000 machine called the SmartCycler System-needed to run it.

(3/18/06)- Laura Landro, in an article that appeared recently in the Wall Street Journal entitled "Hospitals Take Strong Steps Against Bacteria", wrote about now hospitals are fighting back in the battle against drug resistant bacteria. In her article she states, "Each year, studies show, about two million patients-or one in 20- contract an infection after they are admitted to a hospital. This accounts for half of all major complications and 90,000 deaths annually."

Ms. Landro goes on to write, "Medical-supply companies, meanwhile, are offering new products and services to fight bacteria, such as surgical catheters coated with antibiotics, 'killer gloves' that release powerful disinfectants, new diagnostic tests to more quickly identify bacteria, and microbe-resistant bed sheets and lab coats. Five states have passed laws requiring reporting of hospital infections, and several other states are considering such laws."

The article goes on to state that disinfectants are being recognized as a better weapon in the battle against drug resistant bacteria, "because disinfectants work differently, killing bacteria outright, while antibiotics go after bacteria" in a different manner. "They are also using catheters coated with microbe fighting compounds and taking more sterile precautions when inserting catheters and intravenous tubes, where bacteria often enter the bloodstream."

In another step in the battle against drug resistant bacteria, some hospitals are now bathing patients by hand with soap and water from a basin. Nurses instead are wiping the patients down with disposable cloths saturated with chlorhexidine combined with moisturizer.

Emphasis continues to be on cleanliness in the hospital setting. Keeping the hands of both the hospital staff and the visitors to the hospitals continues to be the most important step in the fight against drug resistant bacteria in the hospital setting.

(1/26/06)- The January 20 edition of the Wall Street Journal had an article about how drug resistant bacteria have now spread beyond the walls of our hospitals. The article entitled: "Defying Treatment, A New, Virulent Bug Sparks Health Fears" by Marilyn Chase deals with the drug resistant staph infection known as community-associated methicillin-resistant staphylocuccus aureus, or CA-MRSA.

The infection first appears in the form of bumps with black tops that become red-hot abscesses and require immediate care. It kills up to one-quarter of those who are infected. There is no known anti-biotic that can stop it, but Pfizer's Zyvox has had some degree of success in dealing with some of the cases of the illness.

According to an article in this month's Journal of Infectious Disease Control and Prevention more than two million people carry the drug resistant staph without symptoms. These individuals can spread the disease, or suddenly become ill themselves with it. Matthew Kuehnert, a medial epidemiologist at the U.S. Centers for Disease Control and Prevention wrote the article. In a separate study based on data from 1999 and 2000, Dr. Kuehnert estimates there are 292,000 hospitalizations a year for staph infections and 126,000 of them are drug resistant.

Once the bacteria gets going it produces a poison that kills white blood cells that are used to fight infections, and destroys the body's tissues. With the problem now out in the "healthy" community, the epidemic is causing extreme alarm at the CDC.

The CDC will be publishing the findings of an expert panel on the CA-MRSA it held in July 2004, along with educational materials for doctors and the public. There is a screening test for the disease but it is costly especially if you are going to test everyone that comes down with a bacterial infection.

(8/11/05)- American troops who have been wounded in Iraq and brought back to military hospitals in the U.S. have been found to have a very high rate of a drug-resistant type of bacteria known as Acinetobacter baumannii. This is the same bacterium that caused the problem during the Vietnamese war. The bacteria has been treated by doctors using antibiotics including amikacin and imipenen, but in some cases this has not worked.

About 240 cases have been treated at Army hospitals since 2003, with about 40 of the cases being treated at the National Navy Medical Center in Bethesda, Md. No American solders from the war in Iraq have died from the bacteria, but five very ill patients in the same hospitals as wounded solders became infected and subsequently died. It is not known whether the bacteria or the patients' underlying illness caused their deaths

According to experts from the CDC the bacteria is extremely hardy, and in one experiment proved capable of living on surfaces for up to 20 days. According to Dr. Andrew Short, a pulmonary and critical care specialist at the Washington Hospital Center, "It has implications for our Veterans Affairs system. If our veterans bring it into the hospitals, the system will have to be very diligent with infection control."

(7/7/05)- All hospitals in New York State will be required to report infections contracted by patients in the state during hospital stays under legislation recently enacted. Governor George E. Pataki is expected to sign the legislation. All hospitals in the state will be required to file the report with the State Health Department starting in 2006. It is expected the state health department will publish reports on the infection rate at state hospitals starting in 2007.

(6/19/05)- Wyeth Inc. announced that it had received approval from the FDA to begin marketing of its new antibiotic drug Tygacil. The drug is part of a new class of medicines called glycylcyclines. The drug is under review elsewhere in the world, including Europe, Canada, Mexico and Taiwan. It is an intravenous drug that treats a wide variety of potentially fatal infections, but it has been approved for stomach and skin infections, including burns, ulcers and abscesses.

Glycylcyclines is a new class of antibiotic that is able to fight some drug resistant infections. Johnson & Johnson is working on developing the antibiotics ceftobiprole and doripenem to combat drug resistant bacteria. Pfizer Inc. has also won approval for its Zmax antibiotic to treat mild-to-moderate infections and pneumonia. Pfizer hopes that this drug will replace Zithromax, the patent for which drug expires later this year.

(6/15/05)- California has the largest number of drug-resistant TB cases in the U.S. according to a report from Reuben Granich of the CDC as published in a recent edition of JAMA. The state's 37 cases of multidrug-resistant TB in 2004 reflects an increasing portion of the nation's total drug-resistant cases, from about one-fifth in 2001 to an estimated one-third today.

The greatest bulk of the California cases involves people who were born outside the U.S. Overall however there has been a 76% decrease in drug resistant TB since 1993. Twenty-seven of the cases arose among the 3,400 Hmong refugees who have come to California since June 2004. Drug-resistant TB arises when doctors prescribe ineffective drugs, or patients stop taking their medications and thus allow different strains of the bacteria to multiply.

Once a drug-resistant strain arises, it can pass from person to person with the costs increasing at least ten fold from the standard 6 months treatment which costs about $2,000.

(12/14/04)-A study done by researchers from the Alameda County Medical Center in Oakland and the University of California at San Francisco found that 51% of 137 patients seeking emergency treatment had methicillin-resistant Staphylococcus aureus (MRSA). Although there were no deaths in the group this infection often can prove to be fatal.

Generally, the problem of antibiotic resistance stems from overuse of drugs. Recent outbreak of MRSA skin infections has hit prisoners, homeless people, sports teams and gay men. Medical professionals however have found that the bug may respond to treatment from sulfa compounds and tetracycline, but did not respond to beta-lactam antibiotics like cephalosporins.

(3/08/04)-The FDA is expected to approve a new antibiotic drug Ketek, which is manufactured by Aventis SA which has been tested and shown to be effective in the fight against several strains of drug resistant bacteria that cause pneumonia and bronchitis. Although the drug has been approved for usage in Europe, it has been under regulatory review in this country for over 4 years. It was approved for sale in most Latin American countries in 2002 and in Japan in October of 2003.

Ketek is a once a day pill usually taken for about 5 days. It is the first drug in a new group of antibiotics called ketolides that kill bacteria by clogging the mechanisms that bacteria use to make proteins. It is estimated that more than one-fourth of strains of a common bacterium that cause pneumonia in the U.S. are resistant to penicillin according to the researchers at Aventis. These same researchers have estimated that nearly a third of some pneumonia-causing bacteria have developed resistance to the macrolide family of antibiotics that includes Pfizer's Zithromax, which had over $2.1 billion in sales last year.

Aventis submitted Ketek for review to the FDA in 2000, but the delay it has encountered has been directly related to the problems that arose from two other antibiotics just about at that time. The negative side effects from Pfizers' Trovan, which caused fatal liver damage to some of the patients, and from GlaxoSmithKline PLC Raxar which triggered irregular heartbeats in some of the users caused the FDA to become much more cautious in approving new antibiotics.

Aventis had to enlarge its study on Ketek, which was expanded to 37,000 patients after the first study, which used 20,000 patients. Aventis submitted the results of its second study to the FDA in July 2002. Unlike some medications that are used for long periods of time, if not for lifetimes, the antibiotic type of medication is usually used for only a short period of time. Some drug makers therefore are quite hesitant about putting the amount of money and time needed into the research for antibiotic R& D.

Ketek cleared a big hurdle in January 2003 when an independent panel advising the FDA recommended that it be approved for the treatment of pneumonia, bronchitis and sinusitis. Since then about 5 million additional patients have been treated with Ketek outside the U.S. without suffering serious problems. The most common side effect is diarrhea, which occurred in about 11% of the patients.

According to several studies healthy people, particularly children, are in growing danger from so-called community-acquired staph infections. In particular the MRSA (methicillin resistant staphylococcus aureus) has medical professionals' attention. It can not be treated with the penicillin-related antibiotics that are the normal treatment for staph infections.

Researchers at the University of Texas say that in the period from June 2000 through July 2001, nearly 45% of the children admitted to its facilities with staph infections had the MRSA type that did not respond to first line antibiotics, in comparison to virtually none before 1995. Though the bacteria probably started migrating from the hospitals a few years ago, it is now believed that the bacteria in the public area now has become far more virulent.

A study has found that Cipro, the anti-biotic that became a household name during the anthrax scare after 9/11, is becoming increasingly less effective against other germs because of overuse. Researchers, led by Melinda Neuhauser of the University of Houston concluded that: "More judicious use of fluoroquinolone antibiotics will be necessary to limit this downward trend."

The researchers studied data on infections in hospitalized patients in 43 states and Washington, D.C. from 1994 to 2000. They concluded that many varieties of bacteria had grown resistant to fluroquinolones, a class of antibiotic that includes ciprofloxacin, known by the brand name Cipro. Cipro was effective against 86% of the bacteria samples analyzed in 1994, but that had dropped to 76% by 2000. Once the figures are in for 2001 and 2002, (which would include the period of time when many individuals who did not even have a bacterial infection were using Cipro), this downward trend must surely have declined even more propitiously.

The Food and Drug Administration announced that antibiotic labels will be required to remind doctors several times that antibiotics should be used only in fighting bacteria. Labels will also remind the patients to finish taking the full antibiotic course even if they think they don't need to take them any more. The patient will be warned that failure to stay the course with the medication can cause the bacteria to mutate and later resist the drug.

The new labels must appear on the drug's official label starting February 6, 2006. Amazingly enough, the government estimates that about 1/2 of the 100 million antibiotic prescriptions written annually are for viruses rather than for bacteria infections. This in turn has led to more cases of pneumonia, respiratory-tract infections, meningitis and sexually transmitted diseases that are not responding as well to drugs that normally are used to treat them. "Some bacterial species have developed strains that are resistant to every approved antibiotic," the FDA said

The Centers for Disease Control and Prevention (CDC) has released new guidelines that will change the hand washing procedure for doctors and nurses. The guidelines urge the medical profession to rub a fast drying, germ killing alcohol-based gel on their hands instead of washing their hands with soap and water between patients as a better method in preventing the spreading of germs and bacteria in a medical facility.

I would like to add a personal observation to this new procedure in that I think it should be required of all relatives and friends visiting patients in the ICU units of all medical facilities. I have observed many of these friends and relatives skipping the hand-washing requirement that is clearly posted before you are allowed to visit a patient in the ICU area of a hospital. Little do they realize the degree of risk they are subjecting the patient to by their failure to observe the rules of the ICU area of the hospital.

The CDC hopes that the new procedure will reduce the spread of viruses and bacteria that infect an estimated 2 million hospital patients a year, and result in the death of about 90,000 of them. Many hospitals have installed the new hand washing system already, and it is hoped that the new procedure will cut the rate of infections in half.

The new system is fast and easy to use. Medical professionals will have vials clipped to their uniforms so that they can quickly apply the gel to their hand with a quick swish of the vial. They can then rub their hands together as they walk along thus saving the time that would have been required in walking over to a sink under the old soap and water procedure.

The alcohol-based gel is intended to kill germs not to cleanse the hands of visible dirt. The gel is available in stores under many different brand names. They contain 60% to 90% ethanol or isopropanol.

In addition to the clip on vials that the medical staff will be wearing, dispensers will be available at patients' bedsides, in clinics and in areas wherever there is a high risk of infection. Individual containers of the gel will also be available to staff members of the medical facility.

Whereas Staphylococcus aureus infections were once confined to patients in hospitals, there are now some communities in the United States where up to 30% of these infections occur outside the hospital. In a recent meeting of the International Forum on Antibiotic Resistance the problem of the spreading of the drug resistant bacteria to the community as a whole was brought to the forefront.

Gary Doern, professor of medicine and director of clinical microbiology at the University of Iowa, Iowa City stated: " some patients acquire these infections in the hospital, and then take them home." He went on to state that the problem is worsening with the passage of each year. The problem seems to be arising in many communities outside of, and not connected to the hospital setting.

According to Dr. Doern " There are now patients with pneumococcal infections for whom there is no antibiotic." Dr. Doern also attributed some of the problem to the fact that it is easier for a doctor to write out an antibiotic prescription in 15 seconds than it is for the doctor to spend 10 minutes explaining why it is unnecessary. The erroneous usage of antibiotics to combat viruses that cause colds and flu is one of the leading causes of the problem.

According to the Centers for Disease Control and Prevention, more than 70% of the bacteria that cause hospital-acquired infections are resistant to at least one of the drugs commonly used to treat them. Two million people a year get an infection in a hospital. The National Patient Safety Foundation has issued some guidelines for patients to follow in trying to prevent infections from taking place. Their website address is

Eli Lilly & Co. announced that it had received a "new technology status" approval from the Centers for Medicare and Medicaid Services for its drug Xigris, and that Medicare would reimburse patients for the drug's usage up to $3,400 beginning October 1, 2002.

The company also announced that it had launched the Phase IV study of Xigris in the case of 11,000 adult severe sepsis patients who have a lower risk of death. The primary objective of the study which is called ADDRESS (Administration of Drotrecogin alfa (activated) in Early Severe Sepsis) is to demonstrate that, compared to placebo and conventional care, Xigris will reduce the mortality at 28 days in adult patients with severe sepsis who have a lower risk of death.

The company also replied to an opinion in this week's edition of the New England Journal of Medicine written by Warren et. al. entitled "Risks and Benefits of Activated Protein C Treatment for Severe Sepsis", which questions the protocol, design and outcomes of the PROWESS Phase III trial and study of its sepsis drug Xigris.

Lilly asserts that the decision of the multiple independent authorities that analyzed the clinical data should not be brought into question. This includes the FDA, the CMS and regulatory authorities in 11 other countries. Recently the European Committee for Proprietary Medicinal Products issued a positive opinion on the drug so that Xigris is now approved in the 15 member countries it represents. Xigris therapy has been favorably reviewed and approved for usage in 27 countries to date.

The FDA rebutted the questions of Warren, et al., point by point, and concluded that Xigris will save many lives. It also concluded that the most vulnerable severe sepsis patients, which includes advanced aged patients, are the ones who benefited the most from Xigris therapy.

The Food and Drug Administration had approved Eli Lilly & Co.'s drug Xigris for the treatment of severe sepsis shock in November 2001. Originally the cost for the drug to a typical sized patient was about $6,800. Because it will be a drug of last resort there are many who feel that the drug will be used for advanced sepsis patients no matter what the labeling states. This is because the drug is the first new drug ever to show a reduction in deaths among advanced sepsis patients. About 29% of patients with advanced sepsis die of the condition in the hospital. Xigris reduced deaths from severe sepsis by about 20% in the clinical trials.

Xigris is designed specifically to combat the excessive clotting of the blood. In the trial involving 1,690 patients, 24.7% of Xigris patients died, while 30.8% of those on standard treatment died. In the study 3.5% of the Xigris patients showed serious bleeding, compared to the 2% with serious bleeding in the placebo group. Xigris is the subject of a lawsuit filed in the federal district court in western Oklahoma against Lilly by the Oklahoma Medical Research Foundation for patent infringement.

Prior hereto the FDA's Anti-infective Drug Advisory Committee reached a split decision on whether or not to recommend Xigris (Zovant originally) for approval by the FDA for treatment of severe sepsis. The advisory committee voted 10 Yes and 10 No, with even the Yes voters wanting to restrict the drug's use. The main question in connection with the drug continues to be the risk ratio in that the drug may save lives but is it worth the increased risk of intracranial hemorrage.

Some of the panel members who voted Yes were doubtful in their vote, feeling that the drug would only prolong the life of the patient, who although surviving, would do so in a vegatative state. Some of the panel members were concerned about a decision during the clinical trial to exclude patients who clearly died from causes other than sepsis.

Eli Lilly & Co. originally announced that the FDA had granted its sepsis drug Xigris priority review. According to Lilly this meant that the FDA would take action on the application within a 6-month framework as opposed to the normal 12-month time frame for a standard review. Xigris is the most promising drug to treat sepsis in at least a decade. It is the brand name for drotrecogin alfa, which is used to treat severe sepsis.

There is currently no drug therapy to treat severe sepsis. Originally the FDA had scheduled a review for Xigris for July 17th. This meeting was cancelled. The FDA had requested new data analysis from Lilly. In the clinical trial, 3.5% of Xigris patients suffered serious bleeding, versus the 2% of the placebo patients.

Catalytica a unit of the Dutch company DSM N.V is making the drug for Lilly. The FDA had issued a manufacturing warning letter to Catalytica concerning deficiencies at its plant in Greenville, N.C.

The results of Eli Lilly & Co. Phase III study of the effectiveness of its anti-bacterial drug Xigris was originally announced at the meeting in San Francisco of the Society of Critical Care Medicine. The PROWESS trial was stopped early at the recommendation of an independent Data and Safety Monitoring Board that there had been about a 20% reduction in sepsis deaths as a result of the usage of the drug.

We originally reported that the study was halted in June because usage of Xigris increased the risk of serious bleeding since 3.5% of the patients using it had serious bleeding problems while only 2% of the placebo group developed serious bleeding problems. This is not considered a statistically significant figure.

Although these numbers are correct an e-mail from Dr. Richert Goyette pointed out that the trial was stopped because the trial results met the criteria for reduced mortality among patients treated with Xigris versus those treated with a placebo. According to August M. Watanabe, M.D, executive vice-president, science and technology for Lilly "The data suggest that one in five people who would have died from severe sepsis survived due to Zovant (Xigris)".

Sepsis is a bloodstream bacterial infection that it is estimated afflicts 750,000 Americans annually resulting in the death of about 225,000 of them. Over 1,400 people die worldwide per day as a result of complications from bacterial infections. The study began in 1998 and involved almost 1,700 patients. Patients enrolled in the trial had a mean age of 60.5 years old.

Xigris, is a "recombinant" or bioengineered, version of a naturally occurring human protein called protein C. Sepsis is usually triggered by pneumonia, trauma, surgery, burns, cancer and AIDS. The ICU of the hospitals and premature baby wards seem to be prime locations for staph sepsis. Protein C in the body appears to be extremely low in sepsis patients.

Inserting catheters into the body seems to also cause many of the cases of sepsis. 850 or 24.7% of the patients on Xigris died after 28 days, while 30.8% of the 840 sepsis patients who died were on standard therapy. In severe sepsis some vital organs such as the kidney and lungs become inflamed and shut down. Blood clots form within the blood vessel that oftentimes results in death to the patient.

Up until recently the livestock-drug makers had to show the FDA that their product does not leave any dangerous residue in the meat. The agency however has now changed that ruling so that the maker of a proposed livestock-drug must show that its use would not spur the emergence of disease-causing organisms that resist drugs used to treat humans. The FDA will also re-evaluate the many livestock antibiotics already on the market.

Under the rulings that are contained in a 48-page document, a sliding scale for assessing the risk is created. Thus instead of requiring the immediate withdrawal of a particular drug, the policy would require a phasing out of the usage of such a drug. In 2001, more than 20 million pounds of antibiotics were given to healthy livestock just as a preventive measure and to promote growth. Many of the livestock enhancing drugs are obtained without a prescription. The biggest livestock-drug makers are Bayer AG, Pfizer Inc. and Abbott Labs. The industry as a whole sold more than $4 billion in animal drugs last year.

The FDA is collecting public comments on this topic for 75 days as required by law before finalizing its position. Congress has pending legislation that would phase out 8 livestock drugs for this very same reason. Baytril, which is manufactured by the German company Bayer AG, and is administered to chickens is one of the leading livestock drugs that the FDA has been trying to ban for many years.

In a study done at 19 intensive care units in France it was concluded that steroids may be effective in helping to lower the death rate from severe sepsis. Djillali Annane of the University of Paris led the study. The study was done on 229 patients in the intensive care unit of the 19 different hospitals all of whom had their adrenal glands functioning at a certain level.

There were fewer deaths (60) in the steroid treatment group then among those in the placebo group (73) after 28 days in the hospital, which is a standard measure in intensive care. The steroid group continued to do better than the placebo group after leaving the ICU and the same was true even in their recovery period after their hospital stays.

"One can speculate that two-thirds of the patients with septic shock can benefit from this" Dr. Annane said. These findings were in line with the findings that were written about in a Wall St Journal article on the work of another steroid researcher Dr. G. Umberto Meduri of the University of Tennessee in Memphis.

The article in the Journal written by Thomas M. Burton entitled "Why Cheap Drugs That Appear to Halt Fatal Sepsis Go Unused". One of the sub-titles was "Dr Meduri's 15-Year Quest". Dr Meduri's saga began 15 years ago when a female patient hovering near death because of sepsis in a Connecticut hospital was misdiagnosed. She was given a drug that she should not have been given.

She recovered. The drug that she had erroneously received was a steroid. Dr. Meduri is now at the University of Tennessee Health Center in Memphis. It is his claim that a modest body of evidence now shows that the deadliest forms of sepsis often yield to cheap, common steroids, such as cortisone. A researcher at the University of Paris found that steroids led to a nearly 30% drop in deaths from septic shock. Steroids cost about $50 to administer versus the $6,800 cost for Lilly's Xigris.

Steroids came off of patent protection several years ago. Thus there is no incentive from a financial point of view for the drug companies to pursue this approach to treating sepsis. It has been difficult for him to get funding to follow up on his findings. Dr. Gordon R. Bernard, a Vanderbilt University critical-care specialist was the chief investigator on a 1987 study that showed that steroids were ineffective in treating sepsis, and he also headed the main study showing the effectiveness of Xigris in fighting sepsis. We at therubins have no expertise whatsoever in this matter so we take no stand on it. It is up to the scientific community to evaluate and judge this matter.

Experts at the Centers for Disease Control and Prevention estimate that more than 40% of antibiotics prescribed in doctors' offices are for viral ailments, which antibiotics do not cure. Most respiratory illnesses, which includes colds, bronchitis, ear infections and sore throats are viral not bacterial. There are no simple diagnostic tests, other than strep culture to determine whether an infection is viral or bacterial.

As further evidence of the growing problem that we face in connection with bacteria becoming resistant to many of the drugs being used against them, a popular class of antibiotics is no longer effective in treating strep throats. Up to now, the macrolide class of antibiotics has been used to treat strep throats, because they are "wide" spectrum drugs that attack many different forms of bacteria. Thus the "shotgun" approach rather than the "bullet" approach in the treatment is backfiring.

The finding of the study, which was led by Judith Martin of Children's Hospital in Pittsburgh, was reported in the New England Journal of Medicine. The macrolide class of antibiotics is more convenient and more expensive than using basic penicillin, which would be the "bullet" approach. The study was conducted among a group of private-school children in Pittsburgh.

According to Dr. Martin: "Avoid antibiotic use when it's not necessary because it's contributing to the spread of antibiotic resistance." Stuart Levy, a physician at Tufts-New England Medical Center in Boston concluded that "resistance emerges where antibiotics are widely used,"

Duane Alexander, M.D. and director of the National Institute of Child Health and Human Development (NICHD) announced that the first vaccine against "Staphylococcus aureus" had been developed. The results of the study were published in the February 14, 2002 edition of the New England Journal of Medicine.

The biogenetic firm of Nabi working in conjunction with the NICHD developed the vaccine. According to the announcement the research work over the last 15-years showed that the Staph aureus had 13 capsular polysaccharides of which 2 were causing the problem. The tests were successful on mice and have also showed the capability to produce antibodies in healthy humans.

According to the announcement: "From three to 40 weeks after the start of the trial the vaccine reduced the occurrence of bacteremia by 57%, with 11 bacteremias in the vaccinated group (892 patients) and 26 in the control group (906 patients)."

John Robbins, M.D., chief of the NICHD's Laboratory of Developmental and Molecular Immunity authored the paper along with Rachel Schneerson, M.D. had earlier received the Pasteur and Lasker Awards for work they did in helping to develop a vaccine against "Haemophilus influenzae".

In a blow to Chiron Corp. and Pharmacia Corp., the results of their Phase III trial, Optimist, for the evaluation of their drug tifacogin in severe sepsis, did not meet the primary endpoint of reducing 28-day all-cause mortality.Thus Eli Lilly & Co.'s Xigris remains the only recently approved drug to deal with severe sepsis. The Optimist trial was a double blind, placebo controlled trial of tifacogin involving 2,000 patients from 16 countries.

Because of excessive use of antibiotics the threat of drug-resistant bacteria continues to grow. Researchers now estimate that half of all antibiotics prescribed by doctors are unnecessary. Researchers at the Center for Disease Control studied pneumococcal bacteria and found that the death rate is about 20% when it infects the bloodstream of the elderly. In the period from 1995 to 1998 they concluded that in cases of pneumococcal illness bacteria resistant to three or more classes of anitbiotics increased to 14% from 9%. The proportion resistant to penicillin rose to 25% from 21%. The conclusion of the study was that doctors should not prescribe antibiotics for viral illnesses like colds or the flu. The importance of pneumococcal vaccination was also highlighted in the study. Bacterial infections need anti-biotics while viral infections do not need antibiotics. Most sore throats can't be helped by anti-biotics because they are viral infections. Thus throat cultures should be taken to see if an antibiotic is warranted. By overprescribing antibiotics the chances for drug resistant bacteria is greatly enhanced.

The shotgun use of anti-biotics instead of the rifle approach in human medicine has contributed greatly to the emergence of antibiotic resistance. That is why many doctors are cautioning against taking Cipro, an anti-biotic effective against anthrax unless you have strong reason to believe that you have been exposed to the anthrax spores. Cipro belongs to a class of anti-biotics known as fluoriquinolones, and if it becomes ineffective, many infections could become difficult or even impossible to treat. Included in this class would be effective treatment for pneumonia.

In a recent article in The New England Journal of Medicine, three separate studies showed that antibiotic resistant bacteria are widespread in commercial meats and poultry. Consumers who eat these products have been found to have the anti-biotic resistant bacteria in their intestines. These studies give further credibility to the physicians and scientists who have warned that the routine use of anti-biotics to enhance growth in farm aninmals can encourage the growth of drug-resistant bacteria in the consumers who eat these products. Since genes that confer resistance to drugs can jump from one organism to another, the studies suggest that reistance cna spread to many types of infections. The Union of Concerned Scientists, a nonprofit froup based in Cambridge, Mass., estimated that 26.6 million pounds of anti-biotics are administered to animals each year, with only 2 million pounds used to treat infections in the animals, with the rest being used to speed an improve animal growth. The European Union banned this practice in animals in its jurisdiction 1998.

The Food and Drug Administration acting on the recommendation of the Anti-Infective Drugs Advisory Committee has approved Zyvox (linezolid) to treat infections that are resistant to Vancomycin. Zyvox is also effective against several types of pneumonia and hospital-acquired pneumonia, as well as skin and blood stream infections that arise in hospitals. Pharmacia Corporation has been testing the drug for the last 3 years on over 4,000 patients. The drug is the first in a new class of anti-biotics to be introduced in 30 years. The drug, also known as Oxazolidinones work by inhibiting protein production earlier than other anti-biotics, thus preventing bacteria from multiplying and ultimately killing them. The drug can be administered orally or intravenously. The side effects from the drug include nausea, headaches and vomiting. It has not been approved for usage with children. Pharmacia & Upjohn merged with Monsanto to form a new company called Pharmacia Corporation. The ad for the new company announced that their new product portfolio included "Zyvox (linezolid), the first of a new class of antibiotics in more than 30 years".

It is important to point out that the drug cured only about two-thirds of those infected with the bacteria enterococcus faecium.The strain vancomycin-resistant enterococcus faecium (VREF) first emerged in 1989. About 14,000 people were infected by this bacterium last year. It is feared that if overused, the bacteria will become resistant to this new drug also. Vancomycin costs about $14 per day while it is expected that Zyvox will cost between $175 to $185 per day. Unfortunately staphylococcus aureas continues to outwit most antibiotics, and it infects over 200,000 patients per year. Over half of those infected by the bacteria will die from it.

In the April 6, 2000 issue of the journal Nature, researchers at the University of Wisconsin report they have created a molecule modeled on peptides, the natural proteins that organisms including plants and humans use to kill bacteria. The researchers reported that their synthetic version called a beta-peptide proved active against several drug resistant bacteria including methicillin resistant staphylococcus. They also reported that it may be effective against strains of vancomycin-resistant enterococcus bacteria.

The Center for Disease Control and Prevention confirmed last year that at least 4 children have died from the bacterial infection staphylococcus aureas that did not respond to Vancomycin, the antibiotic of last resort. At least 200 people in North Dakota and Minnesota had become sick with the bacteria. The 27-year-old healthy son of a good friend of ours recently succumbed to the combination of double pneumonia and staph sepsis. If young people are experiencing problems in this area just imagine how great a problem it is for the elderly.

Back in 1947 Penicillin was able to deal with Staph infections. Mutations of bacteria over the years are causing the ability of the bacteria to become more and more drug resistant. The Staph bacteria are found mainly in the nose and throat of all of us, but it is found anywhere in the environment. Anything that causes a breakage of the skin can lead to the infection. Of the 2 million people hospitalized last year with infections, about 13 % suffered from Staph infections. Of that number over half will not survive. It is particularly virulent, and Vancomycin, the drug of last resort is becoming less and less effective against it. For some unknown reason to date there is a higher prevalence of resistant Staph in hospitals and nursing homes. When staph become resistant to methicillin it is given the name MRSA (methicillin resistant staph aureus)

One of the problems that have risen recently in connection with the battle against bacteria is that of "drug resistant bacteria". The Infectious Diseases Society of America (members are infectious-disease physicians) has reported recently that its members have been having problems in getting supplies to treat serious infections such as pneumonia, meningitis, sepsis, endocarditis (a heart infection) and congenital syphillis.The drugs reported to be in short supply include meropenem, ticarcillin/clavulanate, cefazolin, gentamicin or penicillin G.

Experts in this field feel that the shortages have arisen as a result of several factors. One of these factors is the just-in-time philosophy employed by pharmacies, wholesalers and hospitals throughout the country. The shortage of injectable or intravenous anti-biotics is causing doctors to use a "hand grenade " approach instead of a "rifle" approach to treating different infections. By this we mean that the substitute drugs often are designed to kill a broader spectrum of infections than is the more preferred drug aimed at one or two particular types of infections. By exposing the bacteria to an unnecessarily potent and all-inclusive drugs often will result in the arrival of a drug-resistant mutant. Many experts feel that the just-in-time system or carrying a reduced inventory of drugs is counter-productive to having a medical system geared towards the best treatment possible for people who are ill.

A generic drug manufacturing company Marsam Pharmaceuticals of Cherry Hill, NJ had to stop production and recall its production of 2 drugs back in June of 1999. The drugs were penicillin G and cefazolin. This caused a severe shortage of both these drugs at that time in this country. Penicillin G is used intravenously to treat serious infections and cefazolin is a commonly used antibiotic used to treat and prevent surgical infections. Marsam produces about 60% of the penicillin G and about 40 % of the cefazolin produced in this country.

Many doctors feel that one of the reasons for the rise in "drug resistant bacteria" is because of the use of the newer, stronger antibiotics. Although the newer antibiotics kill a wider variety of bacteria, at the same time it causes many different species of bacteria to multiply. Incidentally cefazolin, a generic costs about $5 per dose whereas alternatives cost about $40 per dose.

Gautam Naik writing in the July 27th edition of the Wall Street Journal writes about the possibility of a new deadly mutant strain of malaria that may have arrived in Africa. The article entitled "Deadly Mutant Strain of Malaria Appears to Have Reached Africa" tells of this scary possibility because of the arrival of the strain caused by the plasmodium falciparum parasite. Professor Carol Sibley, a geneticist at the University of Washington in Seattle believes that she may have made this deadly finding.

Dr. Sibley believes she may have found this deadly strain while studying the blood samples of 9 malaria- infected children from Tanzania. It will take many months of additional studies to confirm whether or not this is so. There are four parasite strains that cause malaria, but falciparum is the deadliest of all of them. It last emerged several years ago in parts of Asia and South America after having undergone four mutations. The latest mutation "is especially alarming because it shields the parasite from SP, a mixture of sulphonamide and pyrimethamine that is one of the most affordable and widely used medicines in Africa.

If SP turns ineffective, the human toll from malaria could surge." Scientists feel that there is the hope that the ancient Chinese herb called qinghaosu that may be an effective killer of the parasite. According to the World Health Organization "qinghaosu-based drugs cured more than 90% of malaria in certain countries". The new quinghaosu-based drugs cost about $1 per treatment versus the cost of about 10 cents per SP treatment. In the case of several of the impoverished African nations this cost differential can be extremely difficult to bridge. Novartis AG, the Swiss drug company is making its qinghaosu-based drug treatment available at the sharply reduced cost of $2.40 to the WHO, which will help distribute it in the poorer countries.

See also: Drug Resistant Bacteria and The Importance of Cleanliness-Part II
Drug Resistant Bacteria- Part III- A Continuation of Part I


By Allan Rubin and Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated September 27, 2008

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