Promising New Drug Target For Inflammatory Lung Diseases

The naturally occurring cytokine interleukin-18, or IL-18, plays a key role in inflammation and has been implicated in serious inflammatory diseases for which the prognosis is poor and there are currently limited treatment options. Therapies targeting IL-18 could prove effective against inflammatory diseases of the lung including bronchial asthma and chronic obstructive pulmonary disease (COPD), as described in a review article published in Journal of Interferon & Cytokine Research, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free online at the Journal of Interferon & Cytokine Research website. (http://www.liebertpub.com/jir)

Tomotaka Kawayama and coauthors from Kurume University School of Medicine, Fukuoka, Japan, University of Ryukyus, Okinawa, Japan, and Frederick National Laboratory for Cancer Research, Frederick, MD, review the growing evidence to support the important role IL-18 has in inflammation and how it may help to initiate and worsen inflammatory disorders such as arthritis, dermatitis and inflammatory diseases of the bowel and immune system. In the article "Interleukin-18 in Pulmonary Inflammatory Diseases" (http://online.liebertpub.com/doi/full/10.1089/jir.2012.0029) they describe the potential benefits of therapies aimed at blocking the activity of IL-18 to treat inflammatory lung disease.

"This review provides an interesting and thorough summary of the biology and potential application of IL-18 in the setting of inflammatory pulmonary disease," says Co-Editor-in-Chief Thomas A. Hamilton, PhD, Chairman, Department of Immunology, Cleveland Clinic Foundation.

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Active Ingredient In Florastor Probiotic Clinically Proven To Boost Efficacy Of Treatment For Clostridium Difficile-Associated Disease

C. diff-associated disease (CDAD), otherwise known as severe intestinal disease brought on by the Clostridium difficile (C. diff) pathogen, has been the subject of heightened concern in the medical community. A new report released this month by the federal Agency for Healthcare Research and Quality revealed a 200 percent increase in potentially fatal diarrheal infections in U.S. hospitals between 2000 and 2005. Additionally, the Association for Professionals in Infection Control and Epidemiology (APIC) is launching the first national prevalence study for C. diff beginning May 1.

According to Patricia Raymond, MD, FACP, FACG, a Chesapeake, Virginia-based gastroenterologist, associate professor of clinical medicine at Eastern Virginia Medical School and host of the soon-to-be-launched "Your Health Choice" radio program, traditional treatment for C. diff-associated disease is the use of powerful antibiotics such as metronidazole or vancomycin, but one of the most troublesome aspects of the disease is it's high rate of recurrence. But studies show that adding the yeast-based probiotic Saccharomyces boulardii (sold under the brand name Florastor®), can cut the rate of recurrence by about half.

"Almost one in four CDAD patients will experience a recurrence of symptoms after a round of antibiotic therapy alone," says Dr. Raymond. "C. difficile colitis has been in the news recently as more virulent strains are emerging. These more toxic bugs lead to higher rates of surgery for colon removal and death from the infection. Doctors are using everything in their toolboxes to combat C. difficile, and one of our proven tools is Saccharomyces boulardii. When a relapse occurs, use of Florastor during the antibiotic course can help protect against future relapses."

A recent meta-analysis of 31 studies compiled and published in the American Journal of Gastroenterology concluded that S. boulardii is the only probiotic that is effective in fighting recurrent C. diff-associated disease1 Additionally, an article in the March 2006 issue of Gastroenterology and Hepatology showed that use of S. boulardii provided an almost 50 percent decrease in subsequent recurrence among patients who suffered recurrent CDAD symptoms.2 "Because Florastor (S. boulardii) is a yeast and not a bacteria, it is not killed by the strong antibiotics that are being used to kill the C. diff bacteria, so it survives in the digestive tract," says Dr. Raymond. "When the 'baby' C. diff emerge from their spores, they are greeted by a well-colonized gut, rather than an empty playground."

CDAD is usually indicated by severe abdominal pain, diarrhea with mucous and blood passage, and fever. Dr. Raymond advises those exhibiting these symptoms to see a physician immediately to be tested for the presence of the C. diff toxins and to be prescribed proper antibiotics, since over-the-counter anti-diarrheal agents should be avoided.

"Traditional OTC anti-diarrheal products actually slow down the speed of fluids moving through your bowels, and, in the case of C. diff, keeping the bacteria in the bowels is actually a bad thing," she adds.

Healthcare practitioners are advised to adhere to strict hand-washing policies in offices and hospitals to help prevent the spread of this and other types of bacteria.

Florastor has shown in more than 50 years of extensive international use to be safe and effective, with an estimated 1.7 billion daily doses sold to date. It is mentioned by the World Health Organization (WHO) for use in the management of C.diff-associated disease.3

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After recently undergoing voluntary testing, Florastor has been named to the list of Approved Quality products on ConsumerLab.com, the leading provider of independent test results and information to help consumers and healthcare professionals evaluate health, wellness and nutrition products.

Florastor is available in most retail chain pharmacies, and at independent pharmacies.

Visit http://www.florastor.com/ to find out where to purchase Florastor in your area. It is commonly found in the anti-diarrheal/stomach aid section, and can also be obtained by asking the pharmacist (many stores keep Florastor the product behind the counter).

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"Super Bug" Scares - Straight Facts About Antibiotic Resistance

With recent news about "super bugs," you may wonder if antibiotics are still effective, and whether they will work for you when you need them. You're not alone - there is a lot of confusion about antibiotics - what they do and don't treat, and why they sometimes stop working. It is important to know that antibiotics are effective only if they are prescribed and taken correctly.

Two main types of germs cause most infections - viruses and bacteria. Antibiotics are a type of medicine that can kill or stop the growth of bacteria and help cure the infections they cause. Some people think that antibiotics can be used to treat viral infections, such as a cold or the flu. However, it is very important that you not take an antibiotic for a cold or the flu - doing so can contribute to what experts call "antibiotic resistance." To help you understand when you need to take antibiotics and how you should use them, here are answers to some of the most commonly asked questions about antibiotics and resistance.

Q. What is antibiotic resistance?

A. Antibiotic resistance is the ability of bacteria to resist the effects of an antibiotic. When this occurs, medications used to treat infections caused by bacteria become less effective or not effective at all. When antibiotics are used incorrectly, such as when they are taken when not needed, bacteria can develop new ways to fight the medicine, and they become resistant to antibiotic medications. This can lead to more visits to the doctor, more medication, higher medical bills or even a visit to the hospital.

Q. Do currently available antibiotics still work?

A. Yes. There are still many effective antibiotics available. The best antibiotic is the one that kills the bacteria and stops the infection the first time. Antibiotics are most effective when taken as prescribed by your doctor.

Q. Can an antibiotic be used to treat the cold or the flu?

A. No. Antibiotics only treat illnesses caused by bacteria. Colds and the flu are caused by viruses. Taking antibiotics when you have a virus may cause more harm than good. Your doctor can determine whether your infection is caused by a virus or bacteria.

Q. I was prescribed an antibiotic the last time I was sick, so is it safe to assume that I should probably take an antibiotic again?

A. No. Often, people become confused about whether they should treat the sniffles, a cough and aches with just rest and fluids, or with an antibiotic. Doctors report that many patients see them to request antibiotics even though antibiotics might not be appropriate. Your doctor will decide if an antibiotic is appropriate for you. DO NOT take leftover antibiotics or an antibiotic that was prescribed for someone else. Taking antibiotics when not needed may increase your risk of getting an infection that resists antibiotic treatment.


Q. If I feel better, can I stop taking my antibiotic?

A. No. Take your antibiotic exactly as prescribed - and that means finishing the entire course, even if you feel better. Stopping treatment too soon, even if you feel better, also contributes to resistance because the bacteria may be left to grow and multiply. Taking the complete course helps to make the medication effective, allowing it to kill the bacteria causing the infection and reduce the risk of resistance. If you feel worse or experience a side effect while taking an antibiotic, please consult your doctor.

Remember, antibiotics are strong medications that can stop infections and save lives. Talk to your doctor about whether or not you need an antibiotic and how to use it correctly.

LEVAQUIN® (levofloxacin) is indicated for adults with acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.

Important Safety Information

The most common drug-related adverse events in US clinical trials were nausea (1.5%) and diarrhea (1.2%).

The safety and efficacy of levofloxacin in pediatric patients, adolescents (under 18), pregnant women, and nursing mothers have not been established. Levofloxacin is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product. Serious and occasionally fatal events, such as hypersensitivity and/or anaphylactic reactions, as well as some of unknown etiology have been reported in patients receiving therapy with quinolones, including levofloxacin. These reactions may occur following the first dose or multiple doses. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

As with other quinolones, levofloxacin should be used with caution in patients with known or suspected central nervous system disorders, peripheral neuropathy, or in patients who have a predisposition to seizures.

Tendon ruptures that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin, during and after therapy. This risk may be increased in patients receiving concomitant corticosteroids, especially the elderly. The quinolone should be discontinued in patients experiencing pain, inflammation, or rupture of a tendon.

Some quinolones, including levofloxacin, have been associated with prolongation of the QT interval, infrequent cases of arrhythmia, and rare cases of torsades de pointes. Levofloxacin should be avoided in patients with known risk factors such as prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III (amiodarone, sotalol) antiarrhythmic agents.

Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx®* (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should be taken at least 2 hours before or 2 hours after levofloxacin administration.

For information on Warnings, Precautions, and additional Adverse Reactions that may occur, regardless of drug relationship, please see full Prescribing Information.

Videx is a registered trademark of Bristol-Myers Squibb Company.

PriCara
http://www.pricara.com/

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The truth about Anabolic Steroids

At school they're called roids, juice, gym candy, pumpers, stackers, weight trainers or hype. They're anabolic steroids and they can hurt you.

Looking cool can be very important. Some things like cool clothes and hair styles are great. Messing with your body is not cool.

Performance enhancing drugs, like steroids, were at first used by athletes to improve their athletic abilities and provide them with an advantage in their competitive sport. However in recent years, young people, like you, have been taking these man-made substances.

Steroid use is dangerous and can lead to serious medical and psychological complications. It is important that you understand the consequences of taking steroids.

What are anabolic steroids?

Anabolic steroids are synthetic or man-made substances related to testosterone. Testosterone is the male sex hormone that is responsible for the growth of bones and muscles, and for the development of masculine features such as, facial hair and a deeper voice.

It also increases muscle mass and muscle strength. Although it may take a little longer, you can get the same effects by following a supervised and safe weight training program and good nutrition.

Steroids are controlled substances, available by prescription and are used to treat specific medical conditions. It is not illegal to possess steroids for personal use, but possession for trafficking is illegal.

Since steroids are illegal to get without a doctor's prescription, this has resulted in a widespread black market supply of steroids. Steroids obtained through illegal means may be counterfeit (not the same as you would get from a doctor) and possibly impure.

Steroids are taken by mouth as tablets or capsules, by injection into muscles, or as gels or creams that are rubbed into the skin. Doses taken by people who abuse steroids can be up to 100 times greater than doses used for treating medical conditions.

Who uses steroids?

Steroid users are not necessarily just professional athletes. You may be thinking of using steroids to change the way you look, and 'bulk up' or build muscle to help you feel better about yourself. You may be thinking that you can become more popular and get more respect and sex appeal.

About 83,000 young Canadians, mostly young men, between the ages of 11 and 18 report using steroids at least once.

Of those young Canadians who use steroids, about half use steroids to improve their performance in sports; almost as many use steroids to change their physical appearance.

Most steroid users are male, white, middle class and age 14 or older. The majority are involved in a regular physical activity or fitness/weight training program.

Women between the ages of 11 and 18 are less likely to use steroids. It's mainly a male issue.

Do you know the side effects of using steroids?

Steroids have dangerous side effects. However, many of the consequences don't appear until much later. If you are relying on advice from other users and friends, they may not know or tell you about the dangers.

Steroids affect the way you look:

Severe acne (pimples) of face and body

Hair loss

In teenagers, steroids can stop bones from growing, so you may not grow to your full height

In girls, steroids may cause masculine features like more body hair, smaller breasts, deeper voice, and larger clitoris

Breast enlargement in boys

Steroids affect your sex drive:

In boys, steroids can shrink your testicles and cause impotence (can't get it up)

In girls, you can have irregular periods

Steroids can affect your personality:

'Roid rage' where you may become more aggressive or violent, and have bursts of anger

depression

mood swings

being tired

Steroids can threaten your life:

If you inject steroids and share needles or vials, you can become infected with Hepatitis B and C, and HIV (AIDS)

Damage to liver and liver cancer

Damage to kidneys

High blood pressure

High cholesterol leading to higher chance of getting a heart attack or stroke What can you do instead of taking steroids?

Even though steroids increase the size of your muscles, they can damage your health.

You can talk to your gym teachers and/or coaches to get information about nutrition, exercise, and other training techniques for improving performance. You can ask your teachers and/or coaches to talk to other young people about the dangers of using steroids.

You can feel good about yourself based on other things, not just your physical appearance. You should be proud of your talents, achievements, abilities, intelligence, sense of humor, etc.

It may take you longer, but you can get fit and build muscle without using steroids. You can feel proud of yourself by setting goals and achieving them without the use of steroids.

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FDA Bans Certain Uses Of Antibiotics In Food-Producing Animals

In a bid to protect an important class of antibiotics for treating humans and reduce the development of drug resistance, the US Food and Drug Administration has banned certain uses of cephalosporins in food-producing animals. The federal agency announced on Wednesday that the prohibition order comes into effect on 5 April.

The ban is intended to stop the use of "extra label" or unapproved use, of cephalosporins in what the FDA describes as the "so-called major species of food-producing animals" such as cattle, pigs (swine), chickens and turkeys.

Use of antibiotics in food-producing animals, whether for treatment, disease prevention or growth promotion, allows resistant bacteria and resistance genes to develop and spread from those animals to humans through the food-chain.

Michael R. Taylor, the FDA's Deputy Commissioner for Foods, told the press:

"We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals."

Cephalosporins are a class of antimicrobial drug commonly used to treat bacterial infections in various parts of the body such as throat, ears, lungs, sinuses and skin. They are increasingly seen as an effective alternative to penicillin for many patients.

Doctors prescribe them for the treatment of pneumonia and soft tissue infection, plus various other conditions such as pelvic inflammatory disease, diabetic foot infections, and urinary tract infections.

If cephalosporins are not effective in treating these conditions, then doctors have to resort to other drugs that are less effective and have worse side effects.

The FDA says the new ban takes into account the "substantial public comment" they have received on a similar order the agency issued in 2008 but then revoked prior to implementation. This new ban is less of a blanket ban, in that it appears to carefully specify certain exceptions that the agency says will not risk public health.

The reason for the ban is to "preserve the effectiveness of cephalosporin drugs for treating disease in humans", with the intention that such a move will "reduce the risk of cephalosporin resistance in certain bacterial pathogens".

Specifically, the order bans the use of cephalosporins in ways that have not been approved, such as:

• Unapproved dosage levels, frequencies, durations and ways of giving the drug,


• Using cephalosporin drugs in food producing animals that have not been approved for use in those animals (for instance, some cephalosporins are approved only for treating humans or companion animals), and


• To prevent disease in these food-producing animals,

Unlike the ban that was introduced and then revoked in 2008, the new ban does allow some exceptions to the extralabel use of cephalosporins in food-producing animals. These exceptions, which the FDA says "protect public health while considering animal health needs", are:

• The ban does not limit the use of an older drug, cephapirin, which the agency says is not thought to contribute significantly to the development of antibiotic resistance.


• Veterinarians will be allowed to administer or prescribe cephalosporins for "limited extra-label use" in the major food- producing animals, as long as they adhere to the "dose, frequency, duration, and route of administration" specified on the label.


• They will also be allowed to administer or prescribe cephalosporins for "extralabel uses" in minor species of food-producing animals such as ducks or rabbits.

There is an opportunity for the public to comment on the new order of prohibition. The window for this opportunity opens on 6 January and closes on 6 March, 2012.

To find out how to make a comment, go to http://www.regulations.gov and enter "FDA-2008-N-0326" in the keyword box.

The federal agency says it will review the comments before the order of prohibition comes into force on 5 April.

For further information, go to the FDA's own question and answer page.

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Jet Device Injects Drugs Without Needles

The prospect of less painful medicine shots without needles came a step closer this month, as US researchers revealed how they have developed a device that delivers a controlled, tiny, high-pressure jet into the skin without using a hypodermic needle.

While there are already several jet-devices on the market, they tend to be of an "all or nothing" design that delivers the same amount of drug to the same depth each time.

However the new jet-injection device that researchers at MIT have engineered can be programmed to deliver medicine into the skin in a range of doses to variable depths in a controlled manner.

A statement released earlier this week gives details of the new technology, with comments from study leader Ian Hunter, the George N. Hatsopoulos Professor of Mechanical Engineering at MIT, and some members of his team. Earlier this year, the journal Medical Engineering & Physics also published a paper where they describe the progress of their development.

Hunter and colleagues see a number of advantages to the technology.

One advantage is a reduction in needle-stick injuries. For instance, according to the US Centers for Disease Control and Prevention (CDC), there are around 385,000 cases a year in the US of health workers in hospitals accidentally pricking themselves with needles.

Another advantage of a needle-less device is it may help improve compliance, for instance among diabetes patients who are reluctant to use hypodermic needles to inject themselves with insulin.

Team member Catherine Hogan is a research scientist in MIT's Department of Mechanical Engineering. She said:

"If you are afraid of needles and have to frequently self-inject, compliance can be an issue."

"We think this kind of technology ... gets around some of the phobias that people may have about needles," she added.

Scientists have been working for some time to find alternatives to the hypodermic needle. For instance, nicotine patches are one example of how to release drugs through the skin. But there is a limit to the size of the molecule you can use in a patch: it has to be small enough to pass through the pores of the skin, which rules out larger protein-based drugs, for instance, which are increasing in use.

A jet injector device delivers a high-velocity jet that penetrates the skin. But while these are commercially available, many have spring-loaded designs, they are all limited by the fact they deliver the same amount of drug each time to the same depth of skin.

But thanks partly to a "custom high-stroke linear Lorentz-force motor that is feed-back controlled during the time-course of an injection", the MIT jet injector can deliver a range of doses to variable depth in a highly controlled manner.

The feed-back control aspect of it allows the device to react in "real time" and adjust itself accordingly to meet the programmed instruction.

The Lorentz-force motor is essentially a small, powerful magnet surrounded by a wire coil attached to a piston located inside a drug ampoule.

When an electric current passes through the coil it produces a magnetic field that forces the piston forward, ejecting the drug at very high pressure and speed (nearly as fast as the speed of sound) through the nozzle of the ampoule, which is about the same thickness as the proboscis of a mosquito.

The researchers have shown how using this device, they can monitor and modulate continuously the speed of the drug jet, and "regulate precisely the volume of drug delivered during the injection process", as they write in their paper.

They also report being able to control injection depth up to 16 mm, and "repeatably and precisely inject volumes of up to 250 μL into transparent gels and post-mortem animal tissue".

By controlling the amount of current, the researchers control the speed and pressure. They have generated pressure profiles that modulate the current.

There is a high-pressure phase that ejects drug at a speed sufficient to "breach" the skin and reach the desired depth, and there is a lower-pressure phase that delivers drug in a slower stream that can easily be absorbed by the surrounding tissue.

From tests, the team established that different skin types may require different pressures to deliver the right volume to the right depth in the skin, as Hogan explained:

"If I'm breaching a baby's skin to deliver vaccine, I won't need as much pressure as I would need to breach my skin."

"We can tailor the pressure profile to be able to do that, and that's the beauty of this device," she added.

The team is also developing a version of the device that delivers drugs normally dispensed in powdered form: by programming the device to vibrate, the powder becomes "fluidized" and can penetrate the skin like a liquid.

This version would be very useful in situations where there is risk of a "cold chain" problem. This problem is not uncommon in developing countries, where whole batches of drugs and vaccines have to be destroyed if they can't continuously be kept refrigerated in liquid form.

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Hep C Vaccine Shows Promise In First Trial

An experimental vaccine against the chronic liver disease hepatitis C has shown promising results in its first clinical trial in humans, say researchers from the University of Oxford, UK, who write about their findings in the 4 January online issue of Science Translational Medicine. However, they caution there is still a long way to go before we have an effective vaccine ready for clinical use.

There is currently no vaccine for hepatitis C virus (HCV), a major pathogen transmitted through the blood that infects some 170 million people around the world. The infection can remain hidden without showing symptoms for years, and many people don't know they are infected.

The disease is now the main reason people in Western countries have liver transplants.

A feature of HCV is that its course is unpredictable. Some people can become infected and then gradually experience liver damage, while others, a small minority, seem to have sufficient immunity that they clear the virus soon after infection.

In the trial, the experimental vaccine generated immune responses similar to those seen in these few people with natural immunity.

The researchers hope their findings mean in time, it may be possible to develop a vaccine that will be broadly effective and offer lifelong protection against HCV, or help treat those already infected.

They warn however that several more studies over several years must be done first before such a hope can become a reality.

Senior investigator Paul Klenerman, a professor in the Nuffield Department of Clinical Medicine at Oxford University, told the press:

"The immune responses we've seen are exciting and we are beginning the next stage of trials. While we are hopeful, it could be a long road to any vaccine that protects people against hepatitis C."

A key feature of the study, is that the Oxford researchers, with colleagues from an Italian biotech company and the University of Birmingham in the UK, departed from a traditional approach and went in a new direction.

The reason they went a different way is because of another feature of HCV: it is always changing its make up, in that respect it is similar to HIV. This makes it difficult to pick a target that will be there for some time and make an effective building block for a vaccine.

So the researchers turned to a new idea: they picked a target in the virus that is less likely to change: an internal part, rather than the more traditional approach of picking something on the surface of the virus.

Klenerman explained:

"The outside shell of the hepatitis C virus is very variable but the inside of the virus is much more stable. That's where the engine of the virus is, where we may be able to successfully target many of the crucial pieces of machinery."

Choosing a more constant internal virus part as a target would also stimulate a different type of immune response from what had been attempted in previous studies to develop an HCV vaccine.

".. we need T cells and not antibodies to be able to react to the inner components of the virus," said Klenerman.

So he and his colleagues set out to boost HCV-specific T cells using a "recombinant adenoviral vector strategy" in human volunteers. In total, 41 healthy adults took part in the study.

In their paper the researchers describe how they adapted two adenoviruses to carry NS (nonstructural) proteins from HCV genotype 1B. One adenovirus was sourced from a rare human serotype (Ad6, human adenovirus 6) and the other from chimpanzee (ChAd3, chimpanzee adenovirus 3).

They found that:

"Both vectors primed T cell responses against HCV proteins; these T cell responses targeted multiple proteins and were capable of recognizing heterologous strains (genotypes 1A and 3A)."

The HCV-specific cells that the response elicited consisted of a broad range, including both CD4+ and CD8+ subsets, "secreted interleukin-2, interferon-[gamma], and tumor necrosis factor-[alpha]".

The researchers note that the response "... could be sustained for at least a year after boosting with the heterologous adenoviral vector", and that further study showed the presence of "... long-lived central and effector memory pools that retained polyfunctionality and proliferative capacity".

They conclude that the findings show it is possible, using an adenoviral vector strategy, to induce "sustained T cell responses" of sufficient size and quality to confer protective immunity and "open the way" for further research into an effective vaccine and treatment for HCV.

The purpose of this phase 1 study was primarily to establish the vaccine is safe, and to record the kind of immune response it generates. The results show that the vaccine appeared safe in the group that took part in the study, and no significant adverse reactions were reported.

Klenerman said they were excited by the immune responses they observed in this phase 1 trial and that the next phase is already under way.

The Oxford team is now starting a trial to see if the experimental vaccine can treat those already infected with HCV, and they also want to continue to develop it to elicit stronger immune responses.

"T cell responses often become weak in those with chronic hepatitis C infections," said Klenerman. "It may be that using a vaccine to boost their immunity could become part of any treatment with other drugs."

Another team in the US also looking to conduct a larger trial in an at-risk population to see if the vaccine can protect against HCV infection.

Funds from the European Commission, the UK Medical Research Council, the Wellcome Trust, the Oxford Biomedical Research Centre, and the Oxford Martin School at the University of Oxford, helped pay for this phase 1 study.

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HPV Vaccine Not Linked To Autoimmune Disorders, Study

A two-year study of nearly 190,000 girls and women, finds that Gardasil, the human papillomavirus (HPV) vaccine made by Merck & Co, does not trigger autoimmune disorders such as lupus, rheumatoid arthritis, type 1 diabetes and multiple sclerosis. The results are published in the Journal of Internal Medicine.

Study lead author Dr Chun Chao, a research scientist at the Kaiser Permanente Department of Research & Evaluation in Pasadena, California, said in a statement released on Friday, that:

"This kind of safety information may help parents with vaccination decisions."

""These findings offer some assurance that among a large and generalizable female population, no safety signal for autoimmune conditions was found following HPV4 vaccination in routine clinical use," said Chao.

Gardasil is a "quadrivalent" vaccine because it helps protect against 4 types of HPV. In girls and young women age 9 to 26, it targets 2 types that cause about 75% of cervical cancers, and 2 other types that cause 90% of cases of genital warts.

The vaccine, which is given as three injections over six months, also helps protect boys and men age 9 to 26 against 90% of cases of genital warts.

Genital warts is the most common sexually transmitted infection in the US, where it infects about 6.2 million people every year. It can also lead to cervical cancer in women.

Gardasil received US Food and Drug Administration (FDA) approval in 2006. But a longstanding concern about links with autoimmune disorders has surrounded the vaccine, and many parents won't let their children be vaccinated because of this.

However, Chao and fellow co-investigators from Kaiser Permanente told the press "most speculated associations have stemmed from case reports that have not been confirmed by large, controlled epidemiologic studies", and their investigation "presents findings from a well-designed, post-licensure safety study of the vaccine on a large, ethnically diverse population".

For the study, Chao and colleagues used electronic health records of 189,629 girls and women age 9 to 26 years in California. The participants had been followed for six months after receiving each dose of the quadrivalent HPV vaccine in 2006-2008.

They found no increase in any of 16 autoimmune disorders in the vaccinated population compared to a matched population of non-vaccinated girls and women. The 16 autoimmune disorders they looked for were:

"... immune thrombocytopenia, autoimmune hemolytic anemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, type 1 diabetes, Hashimoto's disease, Graves' disease, multiple sclerosis, acute disseminated encephalomyelitis, other demyelinating diseases of the central nervous system, vaccine-associated demyelination, Guillain-Barré syndrome, neuromyelitis optica, optic neuritis and uveitis."

The researchers explained that the clinical trial data on the vaccine, and the subsequent adverse event reports, have important limitations when it comes to assessing its safety profile.

This is because clinical trials are often based on a highly selected group of participants, the sample sizes are too small, and the follow up is too short, to catch rare safety events such as autoimmune disorders.

And the adverse event reports are not easy to interpret because there is no comparison group, and it is hard to tell if the condition developed before or after the vaccine.

So in their study, Chao and colleagues used methods like in-depth reviews of medical charts to ensure accuracy of diagnosis and that the disease occurred after vaccination. Plus, disease incidence in the vaccinated group was contrasted with incidence in a comparable unvaccinated group.

The results showed that:

• Overall, there were 1,014 new-onset cases of an autoimmune disorder, of which 719 were eligible for case review, and 31 (40%) were confirmed as new onset (ie emerged after vaccination).


• Of these cases, "no cluster of disease onset in relation to vaccination timing, dose sequence or age was found for any autoimmune condition".


• None of the estimated incidence rate ratios was signficantly raised, except that for Hashimoto's disease (IRR = 1.29, 95% confidence interval: 1.08-1.56).


• "Further investigation of temporal relationship and biological plausibility revealed no consistent evidence for a safety signal for autoimmune thyroid conditions."

The authors note that neither the investigators, nor an independent safety review committee, found any autoimmune safety concerns in the study.

The study appears to have been well received by experts not connected to the investigation.

Dr. Harry Fischer, chief of the division of rheumatology at Beth Israel Medical Center in New York City welcomed the findings and described the study as well-designed:

"This article speaks to the safety of the vaccine and helps to confirm that it does not contribute to the development of autoimmune diseases," he said, in a report from USA Today.

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What Is Chemotherapy? What Are The Side Effects Of Chemotherapy?

Chemotherapy is the use of chemicals (medication) to treat disease - more specifically, it usually refers to the destruction of cancer cells. However, chemotherapy also includes the use of antibiotics or other medications to treat any disease. This article focuses on chemotherapy for cancer treatment. Cytotoxic medication prevents cancer cells from dividing and growing. When health care professionals talk about chemotherapy today, they generally tend to refer more to cytotoxic medication than others.

How did chemotherapy start?

After a military operation in World War II some sailors were accidentally exposed to mustard gas. They were later found to have very low white blood cell counts. White blood cells usually grow very quickly - cancer cells also divide and grow very quickly.

The doctors wondered whether the effect of mustard gas - slowing down the rapid growth of white blood cells - may have the same effect on cancer cell growth.

Doctors tried testing patients with advanced lymphomas by injecting a chemical in mustard gas. Even though the effect was temporary, the patients did experience a remarkable improvement.

This led to research into other substances that might slow down or stop the division and growth of cancer cells. Over the decades several new improved drugs were created.

There are more than 100 different types of chemotherapy drugs today which can treat most cancers.

Genetic testing is helping doctors target chemotherapy more accurately. Testing for genetic mutations can help identify breast cancer patients who will not benefit from a specific type of chemotherapy, scientists from the USA and Norway reported.

Chemotherapy has five possible goals

• Total remission - to cure the patient completely. In some cases chemotherapy alone can get rid of the cancer completely.


• Combination therapy - chemotherapy can help other therapies, such as radiotherapy or surgery have more effective results.


• Delay/Prevent recurrence - chemotherapy, when used to prevent the return of a cancer, is most often used after a tumor is removed surgically. Scientists at the Charite School of Medicine, Germany, found that the use of the drug gemcitabine for chemotherapy significantly delays the recurrence of cancer, compared to no chemotherapy.


• Slow down cancer progression - used mainly when the cancer is in its advanced stages and a cure is unlikely. Chemotherapy can slow down the advancement of the cancer.


• To relieve symptoms - also more frequently used for patients with advanced cancer.

How does chemotherapy work?

When our body cells are damaged or die we produce new ones to replace them. This is done in an orderly way, in a balanced way. Cancer cells do not have that orderly capacity - their reproduction (division and growth) is out of control - more and more of them are produced and they start to occupy more and more space, until eventually they push out space occupied by useful cells.

Chemotherapy (chemo) drugs interfere with a cancer cell's ability to divide and reproduce. Chemo drugs may be applied into the bloodstream to attack cancer cells throughout the body, or they can be delivered directly to specific cancer sites.

Chemotherapy drugs work in various ways:

• Impairing mitosis (prevent cell division) - these are known as cytotoxic drugs.


• Targeting cancer cell's food source, enzymes and hormones they require in order to grow.


• Stopping the growth of new blood vessels that supply a tumor. In a study, researchers at the Johns Hopkins University School of Medicine discovered how a whole class of commonly used chemotherapy drugs can destroy cancer by blocking blood vessel growth.


• Triggering suicide of cancer cells - cell suicide is known medically as apoptosis.

Patients may receive monotherapy or combination therapy:

• Monotherapy - the patient is given just one drug.


• Combination therapy - the patient receives more than one drug.

Which type the patient receives will depend on the kind of cancer the patient has, as well as some other health considerations.

Chemotherapy may be given at different stages

• Neo-adjuvant therapy - if the tumor is large the surgeon may want to shrink it before surgery. This may involve some pre-operative chemotherapy and/or radiotherapy.


• Chemoradiation therapy - the chemotherapy is given in combination with radiotherapy. Patients with localized Hodgkin's lymphoma where the tumor is situated above the diaphragm should be given chemotherapy combined with radiotherapy, European scientists reported after carrying out a clinical trial. Another study reported that the solid tumor cells that survive chemoradiation therapy often end up stronger than they were before.


• Adjuvant therapy - chemotherapy given after surgery. The use of chemotherapy following surgery reduces the risk of death from operable pancreatic cancer by around 30%, a UK study found.

Often age will determine whether chemotherapy should be used at all for patients with certain cancers. Researchers at The Mayo Clinic, USA, found that the combination of chemotherapies 5FU and oxaliplatin compared to 5FU alone after surgery for colon cancer decreases colon cancer recurrence and promotes longer survival for patients under 70 - but not for those who are older.

How long is a course of chemotherapy?

In the majority of cases for best results the patient will need regular chemotherapy over a specific period. A protocol plan is drawn up which specifies when treatment sessions will occur and for how long.

A course of chemotherapy may be just a one-day treatment, or can last for a few weeks - it will depend on the type and stage of the cancer (how advanced it is). If the patient requires more than one course of treatment there will be a rest period for his/her body to recover. This could be a one-day treatment followed by a week's rest period, followed by another one-day treatment followed by a three-week rest period, etc. This may be repeated many times.

How many health care professionals are involved in chemotherapy treatment?

This will depend on working practices of your hospital, or even the country you live in. In most countries there will be a multi-disciplinary team who treat the patient's cancer. These may include:

• A clinical oncologist - a doctor who specializes in cancer but does not do surgery. He/she is specialized in chemotherapy.


• A cancer nurse - probably the first person the patient will meet when coming in for chemotherapy.


• A hematologist - this is a doctor who is specialized in the study of blood and bone marrow.


• A pathologist - this is a doctor who specializes in the identification of diseases by examining cells and tissues under a microscope.


• A psychologist - he/she will help the patient deal with the mental and emotional ordeal of chemotherapy.

Blood tests before and during chemotherapy treatment

Blood tests are needed to assess the health of the patient as well as ensuring that he/she will be able to cope with possible side-effects. For example, blood tests can detect liver problems, which could mean that chemotherapy is unsuitable for the patient unless the liver recovers. Chemotherapy chemicals are metabolized (broken down) in the liver which could be harmed if it is not working properly.

Before chemotherapy it is important to test the patient's blood count because the treatment will reduce the number of red and white blood cells, as well as platelets. If a blood test reveals a low blood count the doctors may decide to delay treatment.

Researchers at the Paul Papin Cancer Center in Angers, France, reported that measuring drug levels in patients' blood and adjusting them for optimal dosing can substantially reduce severe toxicity and improve efficacy in colorectal cancer.

Regular blood tests will continue during the treatment period so that the medical team can keep an eye on blood count and the state of the patient's liver. As you may read under side-effects further down this page, there is a risk that chemotherapy may lower white, red, and platelet blood level counts.

Monitoring the patient's blood can also provide doctors with important data on how well the chemotherapy is working.

Two ways of giving chemotherapy

Depending on the type of cancer, chemotherapy may be administered orally or intravenously (directly into the vein).

• Oral chemotherapy (swallowing tablets)
  
  These will be in the form of tablets. If the patient's health allows it he/she will be able to take them at home. However, regular hospital visits will still be needed to check on the patient's health and response to treatment.
  
  It is vital that the tablets be taken exactly when specified. If the patient forgets to take one at a specific time he/she should call the medical team immediately.


• Intravenous chemotherapy (straight into the vein)
  
  Intravenous chemotherapy may be given as:
  
  
  • An injection straight into a vein.
  • Through a drip (intravenous infusion).
  • Through a drip or pump.
  • Through a pump that the patient wears for several weeks or months. This is called continuous infusion, protracted venous infusion, or ambulant infusion (meaning the patient can walk about while receiving the medication).
  There are different ways of getting the medication into the patient. These include:
  
  
  • A cannula - a thin tube is inserted through the skin into the vein - usually it enters the body via the back of the hand or the lower arm.
  
  
  • A drip (intravenous infusion) - in order to dilute the medication it may be injected into a bag. The solution in the bag will pass through a tube into the patients arm and into a vein (intravenous infusion). A cannula will be used. The solution will enter the vein slowly.
    
    Chemotherapy through a drip generally is pushed through with a pump. The pump does not hurry the process up, rather it makes sure the solution enters the vein at a constant rate over a specific period - the slower the rate, the longer the whole thing will take.
  
  
  • A central line - this is a long, flexible, plastic line (thin tube) which ends up in a central blood vessel in the chest, close to the heart. The central line usually enters the body through the center of the chest and goes up under the skin into a large vein by the collarbone (clavicle). The only visible part is the length of line that hangs out of the small entry hole in the chest.
  
  
  • A peripherally inserted central catheter (PICC) line - a long, thin, flexible tube that is inserted into a peripheral vein, usually in the upper arm and makes its way into a large vein in the chest near the heart. It is similar to a central line but has a different point of entry.
  
  
  • A portacath (implantable port) - a thin, soft, flexible plastic tube goes into a vein. It has a port (opening) just under the skin of the chest or arm. The port has a thin rubber disc which special needles can pass medicines into, or take blood from.

Pregnancy and contraception

Many chemotherapy drugs may cause birth defects. It is important that a woman undergoing chemotherapy avoids becoming pregnant. As most chemotherapy medications interfere with oral contraceptives it is important to use a barrier method of contraception, such as condoms, during the whole chemotherapy treatment period and for a year after treatment is completed. If you are pregnant you need to tell the medical team straight away beforehand. If you become pregnant during treatment tell the medical team straight away.

What are the side effects of chemotherapy?

Most people immediately link chemotherapy with uncomfortable side effects. However, side-effect management has improved considerably over the last twenty years. Many side effects that were once inevitable can be either prevented or well controlled today.

There is no reliable way to predict how patients may react to chemotherapy. Some experience very mild side-effect, others will have none at all, while some people will report various symptoms.

Depending on the type of cancer and treatment, chemotherapy may have a bigger impact on the patient's work status than radiotherapy. Women with breast cancer who receive chemotherapy appear more likely than those treated with radiation therapy to experience a major change in work status, according to researchers at the Dana-Farber Cancer Institute.

Below is a list of the most commonly reported side effects:

Nausea and vomiting

Over half of all patients receiving chemotherapy will experience nausea and vomiting. Doctors will usually prescribe anti-emetics for this. These need to be taken even when symptoms have gone as they will prevent them from coming back. If the anti-emetics do not work the patient should contact his/her doctor who may switch to another anti-emetic.

Ginger - scientists at the Rochester University Medical Center found that taking ginger supplements with standard anti-vomiting drugs beforehand can reduce the nausea that often accompanies chemotherapy treatment by 40%.

Alopecia (Hair loss)

Some chemotherapy medications cause hair loss while others don't. If hair does start to fall out this will usually happen a few weeks after treatment starts. On some occasions the hair will just become thinner and more brittle (without falling out). Hair loss can occur in any part of the body.

Although hair loss has no physical health consequences, it may cause distress and embarrassment for some people. The psychological impact tends to be greater among women than men. If you experience hair loss and find it is causing distress and embarrassment, there are several steps you can take:

• Tell your doctor, who may refer you to a counselor who can provide effective help and support.


• Many people find that if they purchase a wig their quality of life improves significantly.


• If there is a cancer support group in your area, go to their meetings. Meeting people who share similar experiences to yourself may help give you a boost, as well as providing you with some useful tips, and possibly an opportunity to make new friends.


• Cold cap - this looks a bit like a bicycle helmet and keeps the scalp cool while the chemotherapy dose is being administered. If the scalp can be kept cool less chemotherapy medication reaches the scalp, thus preventing the occurrence or reducing the severity of hair loss. Some people cannot wear a cold cap - leukemia (blood cancer) patients need the medication to reach their scalp.

The hair loss is NOT permanent - it will grow back soon after treatment if finished.

Fatigue

Most patients receiving chemotherapy will experience some degree of fatigue. This may be a general feeling which exists most of the day, or may only appear after certain activities. Doctors say patients need to make sure they get plenty of rest and not to perform tasks which are overtiring.

While light exercise has been shown to help, it is important to remember to keep the activities 'light'.

If the tiredness becomes severe it is important to tell the doctor, as this could be caused by a significant drop in red blood cells (anemia).

Hearing impairment (deafness, ototoxicity)

Scientists from Oregon Health & Science University reported that deafness as a side effect of chemotherapy has long been underreported by the medical community, because a well-known classification system doctors use for reporting toxicities in patients does not consider high-frequency hearing loss, allowing the magnitude of ototoxicity (hearing damage) in children treated with platinum agents to be miscalculated.

Children with cancer who suffer hearing loss due to the toxic effects of chemotherapy might one day be able to get their hearing back through pharmacological and gene therapy, said researchers from St. Jude Children's Research Hospital after carrying out a study on mice.

Neutropenia (low white blood cells) - Susceptibility to infections

When receiving chemotherapy the immune system will be weakened because the white blood cell count will go down. White blood cells form part of our immune system - they fight infection. Consequently, patients become more susceptible to infections.

Some patients will be prescribed antibiotics which may reduce their risk of developing infections. The following precautions will help reduce the risk of infections:

• Personal hygiene - the cleaner you are, the fewer bacteria there will be around which can infect you. Regularly wash your hands with warm water and soap, have a bath/shower at least once a day, change your clothes and bathroom towels and flannels daily. Change your bed linen regularly.


• Preparing food - make sure your food is free of food borne pathogens (organisms, such as bacteria that can make you ill). If you handle raw meat make sure you wash your hands before touching plates and cutlery or work surfaces. Thoroughly cook animal sourced proteins before eating them. Wash your dishes thoroughly and always use a clean plate and cutlery - keep the kitchen clean.


• Infected people - stay away from people who are ill. This may include those who just have a temperature.


• Skin wounds - bacteria find it hard to get in through your skin, unless there is a cut. If you graze or cut your skin, clean the area well with warm water, dry it, and cover it with a sterile dressing.

Patients receiving chemotherapy who develop an infection need immediate treatment. This may mean being hospitalized and receiving antibiotics via an intravenous drip.

Thrombocytopenia (low blood platelet count) - Blood clotting problems

Chemotherapy may lower the patient's blood platelet count. A platelet is a type of blood cell that helps the blood to clot (coagulate). Coagulation is essential, otherwise bleeding does not stop. Lower blood platelet counts linked to chemotherapy is a risk, but less so than lower red or white blood cell counts. If you are affected you will bruise more easily, you will be more likely to have nosebleeds and bleeding gums, and if you cut yourself it may be harder to stop the bleeding.

Patient's whose blood platelet counts fall too low will need a blood transfusion.

Below are some steps you may wish to take to reduce your risk of bleeding:

• Shave with an electric razor (or don't shave)
• Avoid hard toothbrushes
• Use kitchen utensils and gardening equipment carefully
• If you are gardening, wear gloves

Anemia (low red blood-cell count)

As well as lowering you white blood cell count, chemotherapy will also lower your red blood cell count. Tissues and organs inside your body get their oxygen from the red blood cells. If your red blood cell count goes down too many parts of your body will not get enough oxygen and you will develop anemia.

People with anemia feel very tired. A patient on chemotherapy who has anemia will feel extra tired - much more tired than straightforward fatigue caused by the treatment. Dyspnea (shortness of breath) is also another symptom of anemia, as are palpitations (when the heart beat is irregular).

Anemia linked to chemotherapy requires immediate treatment. A blood transfusion will bring the red blood cell count back up immediately. Erythropoietin (EPO) is a drug that makes the body produce more red blood cells.

The following foods are rich in iron, which helps red blood cells carry more oxygen. Dark green leafy vegetables, beans, meat, nuts, prunes, raisins, and apricots.

Scientists from The Medical University of Vienna, Austria found that patients with breast cancer who developed anemia during chemotherapy had nearly three times the risk of local recurrence as those who did not.

Mucositis (inflammation of the mucous membrane)

Chemotherapy attacks rapidly dividing cells, such as blood cells, bone marrow cells, and cells of the mucous membranes that line the digestive system - this includes the mouth, esophagus, stomach, intestines, and the rectum to the anus. Chemotherapy may damage and even destroy some of those mucous membrane cells.

Oral Mucositis (in the mouth) - patients more commonly experience symptoms in their mouth.

If symptoms do appear, they will usually do so about 7 to 10 days after treatment starts. The inside of the mouth may feel like sunburn; some people say it feels as if the area had been scalded. Ulcers often appear on the lining of the mouth, the tongue, and sometimes around the lips. The severity of symptoms is closely linked to the strength of the chemotherapy dose.

Some may find it painful when they eat, drink, or even talk. If the ulcers bleed there is a risk of infection.

Caphosol is often prescribed for mucositis.

A clinical trial showed that out of 100 cancer patients that were treated with DAVANAT® and chemotherapy that included 5-FU, none developed mucositis.

As better drugs are appearing, mucositis is becoming less common. Symptoms clear up a few weeks after treatment is completed.

Loss of appetite

Loss of appetite is a common side effect of chemotherapy. It is possible that the chemotherapy, or the cancer itself, affects the body's metabolism. If the loss of appetite is just due to the chemotherapy it will come back when the treatment is finished - although this may sometimes take a few weeks.

The severity of appetite and consequent weight loss depends on the type of cancer and chemotherapy treatment.

Although this is sometimes easier said than done, it is important to keep trying to eat well and take in plenty of fluids. Many patients find that smaller and more frequent meals are easier to get down than the typical three meal-a-day regime. Also, drinking liquids through a straw may result in a better fluid intake.

Patients who become seriously affected by lack of food and liquid intake may need to be hospitalized and fed through a nasogastric tube. The tube goes into the patient's nose and down to his/her stomach.

Nails and skin

Chemotherapy can sometimes cause dry and sore skin. Nails may also become flaky and brittle. The skin may become more sensitive to sunlight. It is important to protect yourself from too much sunlight exposure. This includes staying out of the sun during peak times of the day, using sun blocks, and wearing clothes that provide maximum protection. Surprisingly, scientists at Michigan University, USA, reported that the chemotherapy drug fluorouracil appeared to reduce the appearance of sun-damaged and aging skin as well as the number of potentially pre-cancerous skin patches.

Cognitive problems

About one fifth of patients undergoing chemotherapy report some kind of cognitive problem, including attention, thinking and memory. This can sometimes have an impact on daily tasks. Patients who do experience these symptoms should talk to their doctor, and social worker.

Symptoms may include:

• Shorter attention span; concentration, focus and attention problems
• Memory problems; especially the short-term memory
• Comprehension and understand problems
• Judgment and reasoning problems
• Organizational skills may be affected
• Multitasking problems (performing/thinking about several things at the same time)
• Mood swings

Experts are unsure how much is due to the chemotherapy, and how much is due to fatigue, stress and anxiety that comes with having cancer.

Libido (sex drive) and fertility

For a significant proportion of patients, chemotherapy may result in a lower sex drive (less interest in sex). This is temporary and usually returns after treatment is completed.

Depending on the type of medication administered, chemotherapy may also damage men's sperm. Some women may become infertile. In most cases - though not all - fertility returns after treatment is over.

Men who wish to father children and women who plan to become pregnant one day should discuss possible options with their doctors before starting treatment. It is possible to freeze sperm and embryos.

Bowel movement problems (diarrhea or constipation)

Sometimes when damaged cells in the intestinal tract are rapidly expelled from the body there is a risk of diarrhea. Constipation is also a possible risk for chemotherapy patients. You should talk to your doctor if you experience any unpleasant change in your bowel movements. Symptoms, if they do occur, will do so a few days after chemotherapy begins.

Depression

The risk of developing depression is already higher for patients with cancer. It is normal to feel distressed, anxious, sad and stressed - especially if you are concerned about what the future holds and whether treatment is going to be effective.

It is important that you talk to a member of the medical team if you feel it is all getting to be too much, or if you no longer get pleasure out of the things that you used to like. Joining a support group and talking to people who are going through the same as you and understand how you feel has helped many people with cancer.

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